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1. Effect of Direct Antiviral Therapy Against HCV on CD4+ T Cell Count in Patients with HIV-HCV Coinfection

Author: Pinchera B, Zappulo E, Buonomo AR, Cotugno MR, Di Filippo G, Borrelli F, Mercinelli S, Villari R, and Gentile I
Subjects: hcv, hiv, fibrosis, cirrhosis, daas, cd4+ t cell, coinfection, Immunologic diseases. Allergy, RC581-607
Abstract: Biagio Pinchera, Emanuela Zappulo, Antonio Riccardo Buonomo, Maria Rosaria Cotugno, Giovanni Di Filippo, Francesco Borrelli, Simona Mercinelli, Riccardo Villari, Ivan Gentile Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples “Federico II”, Naples, ItalyCorrespondence: Biagio Pinchera, Email biapin89@virgilio.itBackground: HCV-related liver disease is an important cause of morbidity and mortality in patients with HIV infection. It is well known that the response rates to HCV therapy are similar between HCV-monoinfected patients and HIV-HV coinfected ones. The aim of this study was to evaluate the impact of HCV eradication on CD4 + T cell count in a population of HIV-HCV coinfected patients.Materials and Methods: We enrolled patients with HIV-HCV coinfection attending the Infectious Diseases Unit of the A.O.U. Federico II of Naples, from January 2016 to February 2019, treated with ART (AntiRetroviral Therapy) and DAAs (Direct Antiviral Agents). For each patient, we evaluated HIV and HCV viral load and CD4+ T cell count before starting therapy with DAAs, by SVR12 time and by SVR48 time. Fibrosis was evaluated by the mean of Fibroscan®.Results: Fifty-two patients were enrolled, 40 males. Fibrosis score was F0-F3 in 15 patients and cirrhosis in the remaining 11 (all in Child-Pugh class A). All had been receiving ART, and all were treated with DAAs. Only patient who had not achieved HIV viral suppression for non-compliance also experienced a relapse of HCV infection after the end of DAAs. In all patients, we observed that the CD4+ T cell count at baseline did not show significant variations compared to SVR12 and SVR48 time. We also assessed CD4 count in relation to HIV categories and stage of liver disease, see Table 1. Also, based on the assessments of the subclasses considered, there were no significant changes in the CD4 + T cell count.Conclusion: Our study shows that HCV viral eradication obtained with DAAs in patients with HIV-HCV coinfection is not associated with significant changes in the CD4 + T cell count, regardless of CDC category and stage of liver disease.Keywords: HCV, HIV, fibrosis, cirrhosis, DAAs, CD4+ T cell, coinfection
Published: 2023

2. Diabetes and COVID-19: The potential role of mTOR

Author: Pinchera, B., Scotto, R., Buonomo, A.R., Zappulo, E., Stagnaro, F., Gallicchio, A., Viceconte, G., Sardanelli, A., Mercinelli, S., Villari, R., Foggia, M., and Gentile, I.
Published: 2022
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3. Multi-Criteria Decision Analysis to prioritize hospital admission of patients affected by COVID-19 in low-resource settings with hospital-bed shortage

Author: Durante Mangoni, E., Florio, L.L., Zampino, R., Mele, F., Gentile, I., Pinchera, B., Coppola, N., Pisaturo, M., Luzzati, R., Petrosillo, N., Nicastri, E., Corpolongo, A., Cataldo, M.A., D’Abramo, A., Maffongelli, G., Scorzolini, L., Palazzolo, C., Boumis, E., Pan, A., D’Arminio Monforte, A., Bai, F., Antinori, S., De Rosa, F.G., Corcione, S., Lupia, T., Pinna, S.M., Scabini, S., Canta, F., Belloro, S., Bisoffi, Z., Angheben, A., Gobbi, F., Turcato, E., Ronzoni, N., Moro, L., Calabria, S., Rodari, P., Bertoli, G., Marasca, G., Puoti, M., Gori, A., Bandera, A., Mangioni, D., Rizzi, M., Castelli, F., Montineri, A., Coco, C.A., Maresca, M., Frasca, M., Aquilini, D., Vincenzi, M., Lambertenghi, L., De Rui, M.E., Razzaboni, E., Cattaneo, P., Visentin, A., Erbogasto, A., Dalla Vecchia, I., Coledan, I., Vecchi, M., Be, G., Motta, L., Zaffagnini, A., Auerbach, N., Del Bravo, P., Azzini, A.M., Righi, E., Carrara, E., Savoldi, A., Sibani, M., Lattuada, E., Carolo, G., Cordioli, M., Soldani, F., Pezzani, M.D., Avallone, S., Bruno, R., Ricciardi, A., Saggese, M.P., Malerba, G., De Nardo, Pasquale, Gentilotti, Elisa, Mazzaferri, Fulvia, Cremonini, Eleonora, Hansen, Paul, Goossens, Herman, and Tacconelli, Evelina
Published: 2020
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4. Sotrovimab in Solid Organ Transplant Patients With Early, Mild/Moderate SARS-CoV-2 Infection: A Single-center Experience

Author: Pinchera B., Buonomo A. R., Scotto R., Carrano R., Salemi F., Galluccio F., Guarino M., Viceconte G., Schiano Moriello N., Giaccone A., Gallicchio A., Zappulo E., Villari R., Gentile I., Pinchera, B., Buonomo, A. R., Scotto, R., Carrano, R., Salemi, F., Galluccio, F., Guarino, M., Viceconte, G., Schiano Moriello, N., Giaccone, A., Gallicchio, A., Zappulo, E., Villari, R., and Gentile, I.
Subjects: SARS-CoV-2, Transplant Recipient, COVID-19, Organ Transplantation, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Human
Published: 2022

5. Use of hydroxychloroquine in hospitalised COVID-19 patients is associated with reduced mortality: Findings from the observational multicentre Italian CORIST study

Author: Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, Menicanti, L, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Spinoni, E, Stefanini, G, Vergori, A, Ageno, W, Agodi, A, Aiello, L, Agostoni, P, Moghazi, S, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonaccio, M, Bonfanti, P, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Crosta, F, Pra, C, Danzi, G, D'Ardes, D, Donati, K, Giacomo, P, Gennaro, F, Tano, G, D'Offizi, G, Filippini, T, Fusco, F, Gentile, I, Gialluisi, A, Gini, G, Grandone, E, Grisafi, L, Guarnieri, G, Lamonica, S, Landi, F, Leone, A, Maccagni, G, Maccarella, S, Madaro, A, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Minutolo, F, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rinaldi, M, Rognoni, A, Rossato, M, Rossi, I, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Venezia, A, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Vocciante, L, De Caterina, R, Iacoviello, L, Castelnuovo A. D., Costanzo S., Antinori A., Berselli N., Blandi L., Bruno R., Cauda R., Guaraldi G., Menicanti L., My I., Parruti G., Patti G., Perlini S., Santilli F., Signorelli C., Spinoni E., Stefanini G. G., Vergori A., Ageno W., Agodi A., Aiello L., Agostoni P., Moghazi S. A., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonaccio M., Bonfanti P., Cacciatore F., Caiano L., Cannata F., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Crosta F., Pra C. D., Danzi G. B., D'Ardes D., Donati K. D. G., Giacomo P. D., Gennaro F. D., Tano G. D., D'Offizi G., Filippini T., Fusco F. M., Gentile I., Gialluisi A., Gini G., Grandone E., Grisafi L., Guarnieri G., Lamonica S., Landi F., Leone A., Maccagni G., Maccarella S., Madaro A., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Minutolo F., Montineri A., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Petri F., Pinchera B., Pivato C. A., Poletti V., Ravaglia C., Rinaldi M., Rognoni A., Rossato M., Rossi I., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P. G., Spinicci M., Trecarichi E. M., Venezia A., Veronesi G., Vettor R., Vianello A., Vinceti M., Vocciante L., De Caterina R., Iacoviello L., Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, Menicanti, L, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Spinoni, E, Stefanini, G, Vergori, A, Ageno, W, Agodi, A, Aiello, L, Agostoni, P, Moghazi, S, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonaccio, M, Bonfanti, P, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Crosta, F, Pra, C, Danzi, G, D'Ardes, D, Donati, K, Giacomo, P, Gennaro, F, Tano, G, D'Offizi, G, Filippini, T, Fusco, F, Gentile, I, Gialluisi, A, Gini, G, Grandone, E, Grisafi, L, Guarnieri, G, Lamonica, S, Landi, F, Leone, A, Maccagni, G, Maccarella, S, Madaro, A, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Minutolo, F, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rinaldi, M, Rognoni, A, Rossato, M, Rossi, I, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Venezia, A, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Vocciante, L, De Caterina, R, Iacoviello, L, Castelnuovo A. D., Costanzo S., Antinori A., Berselli N., Blandi L., Bruno R., Cauda R., Guaraldi G., Menicanti L., My I., Parruti G., Patti G., Perlini S., Santilli F., Signorelli C., Spinoni E., Stefanini G. G., Vergori A., Ageno W., Agodi A., Aiello L., Agostoni P., Moghazi S. A., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonaccio M., Bonfanti P., Cacciatore F., Caiano L., Cannata F., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Crosta F., Pra C. D., Danzi G. B., D'Ardes D., Donati K. D. G., Giacomo P. D., Gennaro F. D., Tano G. D., D'Offizi G., Filippini T., Fusco F. M., Gentile I., Gialluisi A., Gini G., Grandone E., Grisafi L., Guarnieri G., Lamonica S., Landi F., Leone A., Maccagni G., Maccarella S., Madaro A., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Minutolo F., Montineri A., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Petri F., Pinchera B., Pivato C. A., Poletti V., Ravaglia C., Rinaldi M., Rognoni A., Rossato M., Rossi I., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P. G., Spinicci M., Trecarichi E. M., Venezia A., Veronesi G., Vettor R., Vianello A., Vinceti M., Vocciante L., De Caterina R., and Iacoviello L.
Abstract: Background: Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19. Objective: We set-up a multicenter Italian collaboration to investigate the relationship between HCQ therapy and COVID-19 in-hospital mortality. Methods: In a retrospective observational study, 3,451 unselected patients hospitalized in 33 clinical centers in Italy, from February 19, 2020 to May 23, 2020, with laboratory-confirmed SARS-CoV-2 infection, were analyzed. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received HCQ with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores, with the addition of subgroup analyses. Results: Out of 3,451 COVID-19 patients, 76.3% received HCQ. Death rates (per 1,000 person-days) for patients receiving or not HCQ were 8.9 and 15.7, respectively. After adjustment for propensity scores, we found 30% lower risk of death in patients receiving HCQ (HR=0.70; 95%CI: 0.59 to 0.84; E-value=1.67). Secondary analyses yielded similar results. The inverse association of HCQ with inpatient mortality was particularly evident in patients having elevated C-reactive protein at entry. Conclusions: HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients. Within the limits of an observational study and awaiting results from randomized controlled trials, these data do not discourage the use of HCQ in inpatients with COVID-19.
Published: 2020

6. Pneumocystis jirovecii pneumonia in an immunocompetent patient recovered from COVID-19

Author: Viceconte G., Buonomo A. R., Lanzardo A., Pinchera B., Zappulo E., Scotto R., Schiano Moriello N., Vargas M., Iacovazzo C., Servillo G., Gentile I., Francesco B., Letizia C., Carmela Domenica C. M., Mariarosaria C., Giovanni D. F., Maria F., Antonella G., Ivan G., Agnese G., Simona M., Fulvio M., Amerigo P., Laura R., Fabrizio S., Alessia S., Francesca S., Grazia T., Irene Z., Viceconte, G., Buonomo, A. R., Lanzardo, A., Pinchera, B., Zappulo, E., Scotto, R., Schiano Moriello, N., Vargas, M., Iacovazzo, C., Servillo, G., Gentile, I., Francesco, B., Letizia, C., Carmela Domenica, C. M., Mariarosaria, C., Giovanni, D. F., Maria, F., Antonella, G., Ivan, G., Agnese, G., Simona, M., Fulvio, M., Amerigo, P., Laura, R., Fabrizio, S., Alessia, S., Francesca, S., Grazia, T., and Irene, Z.
Subjects: 0301 basic medicine, Microbiology (medical), 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), 030106 microbiology, 03 medical and health sciences, 0302 clinical medicine, parasitic diseases, Medicine, Pneumocystis jirovecii, In patient, 030212 general & internal medicine, Aspergillus, General Immunology and Microbiology, biology, business.industry, SARS-CoV-2, Pneumocystis jirovecii Pneumonia, COVID-19, General Medicine, biology.organism_classification, Virology, invasive fungal disease, Infectious Diseases, Pneumocystis carinii, lymphopaenia, Immunocompetence, business
Abstract: Background: Several cases of invasive fungal diseases in patients with COVID-19 have been reported, mostly due to Aspergillus spp., with anecdotic reports of Pneumocystis jirovecii pneumonia (PJP) as co-infections in immunocompromised patients. We describe the first case of PJP in an immunocompetent patient who recovered from COVID-19 pneumonia. Case description: Our patient was hospitalized for 18 d for respiratory failure due to Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pneumonia and successfully treated with continuous positive airway pressure (CPAP) respiratory support, enoxaparin, ceftaroline and intravenous 6 mg of dexamethasone for 10 d, then with oral prednisone tapering. Despite his improved radiological and clinical conditions at discharge, he was admitted again after 18 d for worsening of respiratory conditions. Upon the second admission, a high-resolution CT-scan of the chest showed the development of new ground-glass opacities and P. jirovecii was detected on bronchoalveolar lavage fluid. A therapy with trimethoprim-sulphamethoxazole 20 mg/kg and methylprednisolone 40 mg i.v. bis in die (BID) was started, with improvement of clinical, biochemical and radiological conditions. Conclusions: COVID-19 patients may have multiple risk factors for development of PJP, in particular lymphopaenia and use of steroids. PJP must be ruled out with direct microbiological methods in patients presenting with radiologic and clinical features of possible or probable PJP, even in immunocompetent hosts.
Published: 2021

7. Clinical features of patients with home isolation SARS-COV-2 infection: A multicenter retrospective study in southern Italy

Author: Pisaturo M., De Angelis G., Maggi P., Sangiovanni V., Numis F. G., Gentile I., Masullo A., Rescigno C., Calabria G., Megna A. S., Gambardella M., Manzillo E., Giolitto G., Rossomando A., Buonomo A. R., Macera M., Messina V., Pagano A., Pisapia R., Farella N., Bosso G., Coppola N., Monari C., Sagnelli C., Russo G., Esposito V., Allegorico E., Biagio Pinchera, Catalano M., Salzillo A., Porta G., Scotto R., Pinchera B., Zappulo E., Viceconte G., Moriello N. S., Foggia M., Calo F., Rossomando A. M., Russo A., Liorre G., Paradiso L., Liberti A., Serra C., Vicario F. D., Minerva V., Selva V., Simeone F., De Pascalis S., Pontillo V., Pisaturo, M., De Angelis, G., Maggi, P., Sangiovanni, V., Numis, F. G., Gentile, I., Masullo, A., Rescigno, C., Calabria, G., Megna, A. S., Gambardella, M., Manzillo, E., Giolitto, G., Rossomando, A., Buonomo, A. R., Macera, M., Messina, V., Pagano, A., Pisapia, R., Farella, N., Bosso, G., Coppola, N., Monari, C., Sagnelli, C., Russo, G., Esposito, V., Allegorico, E., Biagio, Pinchera, Catalano, M., Salzillo, A., Porta, G., Scotto, R., Pinchera, B., Zappulo, E., Viceconte, G., Moriello, N. S., Foggia, M., Calo, F., Rossomando, A. M., Russo, A., Liorre, G., Paradiso, L., Liberti, A., Serra, C., Vicario, F. D., Minerva, V., Selva, V., Simeone, F., De Pascalis, S., Pontillo, V., Pisaturo, Mariantonietta, De Angelis, Giulia, Maggi, Paolo, Sangiovanni, Vincenzo, Numis, Fabio Giuliano, Gentile, Ivan, Masullo, Alfonso, Rescigno, Carolina, Calabria, Giosuele, Salomone Megna, Angelo, Gambardella, Michele, Manzillo, Elio, Giolitto, Giancarlo, Rossomando, Annamaria, Buonomo, Antonio Riccardo, Macera, Margherita, Messina, Vincenzo, Pagano, Antonio, Pisapia, Raffaella, Farella, Nunzia, Bosso, Giorgio, Coppola, Nicola, and Group, Covicam
Subjects: medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Isolation (health care), Science, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Home isolation, Mild clinical presentation, Disease, 030204 cardiovascular system & hematology, Asymptomatic, Article, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Epidemiology, medicine, 030212 general & internal medicine, Ecology, Evolution, Behavior and Systematics, business.industry, SARS-CoV-2 infection, Home management, Paleontology, COVID-19, Retrospective cohort study, Space and Planetary Science, mild clinical presentation, home management, home isolation, medicine.symptom, business
Abstract: To describe epidemiological and clinical features of patients confirmed as having SARS-CoV-2 infection and managed in isolation at home. We performed a multicenter retrospective study enrolling all SARS-CoV-2-positive adults evaluated from 28 February to 31 May 2020 at one of nine COVID-19 Units in southern Italy: we included patients receiving care at home and those admitted to hospital. We defined patients with not-severe disease if they were asymptomatic or experienced a mild infection that did not need oxygen (O2) therapy and those with a severe infection if hospitalized and required O2 therapy. We enrolled 415 patients with SARS-CoV-2 infection: 77 were managed in isolation at home, 338 required hospital management. The 77 patients in home isolation were less frequently male than hospitalized patients (55% vs. 64%; < 0.01) and were younger (median age 45 years (IQR:19) vs 62 (IQR 22); p < 0.01), had a lower Charlson comorbidity index (median 0 (IQR2) vs 6 (IQR 3); p < 0.01), and included fewer subjects with an underlying chronic disease (36% vs 59%; p < 0.01). According to a binomial logistic regression analysis, a younger age (OR: 0.96 (95% IC: 0.94–0.98), p < 0.01) and a low Charlson comorbidity index (OR: 0.66 (95% IC: 0.54 –0.83); p < 0.01) were independent factors associated with at-home management. The identification of subjects with SARS-CoV-2 infection who could be managed in home isolation is useful in clinical practice. A younger age and no comorbidities were identified as factors independently associated with home management.
Published: 2021

8. Lopinavir/Ritonavir and Darunavir/Cobicistat in Hospitalized COVID-19 Patients: Findings From the Multicenter Italian CORIST Study

Author: Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Bruno, R, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, My, I, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Ageno, W, Aiello, L, Agostoni, P, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bologna, C, Bonfanti, P, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Chiarito, M, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Dalena, G, Dal Pra, C, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Filippini, T, Maria Fusco, F, Gaudiosi, C, Gentile, I, Gini, G, Grandone, E, Guarnieri, G, Lamanna, G, Larizza, G, Leone, A, Lio, V, Losito, A, Maccagni, G, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Milic, J, Minutolo, F, Molena, B, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Perroni, A, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Visconti, E, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Bruno, Raffaele, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, My, Ilaria, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Ageno, Walter, Aiello, Luca, Agostoni, Piergiuseppe, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Chiarito, Mauro, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesco, Dalena, Giovanni, Dal Pra, Chiara, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Filippini, Tommaso, Maria Fusco, Francesco, Gaudiosi, Carlo, Gentile, Ivan, Gini, Giancarlo, Grandone, Elvira, Guarnieri, Gabriella, Lamanna, Gennaro L F, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Losito, Angela Raffaella, Maccagni, Gloria, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marra, Lorenzo, Maresca, Giulio, Marotta, Claudia, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Perroni, Annalisa, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinicci, Michele, Trecarichi, Enrico Maria, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Visconti, Elena, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Bruno, R, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, My, I, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Ageno, W, Aiello, L, Agostoni, P, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bologna, C, Bonfanti, P, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Chiarito, M, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Dalena, G, Dal Pra, C, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Filippini, T, Maria Fusco, F, Gaudiosi, C, Gentile, I, Gini, G, Grandone, E, Guarnieri, G, Lamanna, G, Larizza, G, Leone, A, Lio, V, Losito, A, Maccagni, G, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Milic, J, Minutolo, F, Molena, B, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Perroni, A, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Visconti, E, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Bruno, Raffaele, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, My, Ilaria, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Ageno, Walter, Aiello, Luca, Agostoni, Piergiuseppe, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Chiarito, Mauro, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesco, Dalena, Giovanni, Dal Pra, Chiara, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Filippini, Tommaso, Maria Fusco, Francesco, Gaudiosi, Carlo, Gentile, Ivan, Gini, Giancarlo, Grandone, Elvira, Guarnieri, Gabriella, Lamanna, Gennaro L F, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Losito, Angela Raffaella, Maccagni, Gloria, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marra, Lorenzo, Maresca, Giulio, Marotta, Claudia, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Perroni, Annalisa, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinicci, Michele, Trecarichi, Enrico Maria, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Visconti, Elena, Vocciante, Laura, De Caterina, Raffaele, and Iacoviello, Licia
Abstract: Background: Protease inhibitors have been considered as possible therapeutic agents for COVID-19 patients. Objectives: To describe the association between lopinavir/ritonavir (LPV/r) or darunavir/cobicistat (DRV/c) use and in-hospital mortality in COVID-19 patients. Study Design: Multicenter observational study of COVID-19 patients admitted in 33 Italian hospitals. Medications, preexisting conditions, clinical measures, and outcomes were extracted from medical records. Patients were retrospectively divided in three groups, according to use of LPV/r, DRV/c or none of them. Primary outcome in a time-to event analysis was death. We used Cox proportional-hazards models with inverse probability of treatment weighting by multinomial propensity scores. Results: Out of 3,451 patients, 33.3% LPV/r and 13.9% received DRV/c. Patients receiving LPV/r or DRV/c were more likely younger, men, had higher C-reactive protein levels while less likely had hypertension, cardiovascular, pulmonary or kidney disease. After adjustment for propensity scores, LPV/r use was not associated with mortality (HR = 0.94, 95% CI 0.78 to 1.13), whereas treatment with DRV/c was associated with a higher death risk (HR = 1.89, 1.53 to 2.34, E-value = 2.43). This increased risk was more marked in women, in elderly, in patients with higher severity of COVID-19 and in patients receiving other COVID-19 drugs. Conclusions: In a large cohort of Italian patients hospitalized for COVID-19 in a real-life setting, the use of LPV/r treatment did not change death rate, while DRV/c was associated with increased mortality. Within the limits of an observational study, these data do not support the use of LPV/r or DRV/c in COVID-19 patients.
Published: 2021

9. Heparin in COVID-19 Patients Is Associated with Reduced In-Hospital Mortality: the Multicenter Italian CORIST Study

Author: Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, and Iacoviello, Licia
Abstract: INTRODUCTION: A hypercoagulable condition was described in patients with coronavirus disease 2019 (COVID-19) and proposed as a possible pathogenic mechanism contributing to disease progression and lethality.AIM: We evaluated if in-hospital administration of heparin improved survival in a large cohort of Italian COVID-19 patients.METHODS: In a retrospective observational study, 2,574 unselected patients hospitalized in 30 clinical centers in Italy from February 19, 2020 to June 5, 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus-2 infection were analyzed. The primary endpoint in a time-to event analysis was in-hospital death, comparing patients who received heparin (low-molecular-weight heparin [LMWH] or unfractionated heparin [UFH]) with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores.RESULTS: Out of 2,574 COVID-19 patients, 70.1% received heparin. LMWH was largely the most used formulation (99.5%). Death rates for patients receiving heparin or not were 7.4 and 14.0 per 1,000 person-days, respectively. After adjustment for propensity scores, we found a 40% lower risk of death in patients receiving heparin (hazard ratio=0.60; 95% confidence interval: 0.49-0.74; E-value=2.04). This association was particularly evident in patients with a higher severity of disease or strong coagulation activation.CONCLUSION: In-hospital heparin treatment was associated with a lower mortality, particularly in severely ill COVID-19 patients and in those with strong coagulation activation. The results from randomized clinical trials are eagerly awaited to provide clear-cut recommendations.
Published: 2021

10. Multi-Criteria Decision Analysis to prioritize hospital admission of patients affected by COVID-19 in low-resource settings with hospital-bed shortage

Author: De Nardo, Pasquale, primary, Gentilotti, Elisa, additional, Mazzaferri, Fulvia, additional, Cremonini, Eleonora, additional, Hansen, Paul, additional, Goossens, Herman, additional, Tacconelli, Evelina, additional, Durante Mangoni, E., additional, Florio, L.L., additional, Zampino, R., additional, Mele, F., additional, Gentile, I., additional, Pinchera, B., additional, Coppola, N., additional, Pisaturo, M., additional, Luzzati, R., additional, Petrosillo, N., additional, Nicastri, E., additional, Corpolongo, A., additional, Cataldo, M.A., additional, D’Abramo, A., additional, Maffongelli, G., additional, Scorzolini, L., additional, Palazzolo, C., additional, Boumis, E., additional, Pan, A., additional, D’Arminio Monforte, A., additional, Bai, F., additional, Antinori, S., additional, De Rosa, F.G., additional, Corcione, S., additional, Lupia, T., additional, Pinna, S.M., additional, Scabini, S., additional, Canta, F., additional, Belloro, S., additional, Bisoffi, Z., additional, Angheben, A., additional, Gobbi, F., additional, Turcato, E., additional, Ronzoni, N., additional, Moro, L., additional, Calabria, S., additional, Rodari, P., additional, Bertoli, G., additional, Marasca, G., additional, Puoti, M., additional, Gori, A., additional, Bandera, A., additional, Mangioni, D., additional, Rizzi, M., additional, Castelli, F., additional, Montineri, A., additional, Coco, C.A., additional, Maresca, M., additional, Frasca, M., additional, Aquilini, D., additional, Vincenzi, M., additional, Lambertenghi, L., additional, De Rui, M.E., additional, Razzaboni, E., additional, Cattaneo, P., additional, Visentin, A., additional, Erbogasto, A., additional, Dalla Vecchia, I., additional, Coledan, I., additional, Vecchi, M., additional, Be, G., additional, Motta, L., additional, Zaffagnini, A., additional, Auerbach, N., additional, Del Bravo, P., additional, Azzini, A.M., additional, Righi, E., additional, Carrara, E., additional, Savoldi, A., additional, Sibani, M., additional, Lattuada, E., additional, Carolo, G., additional, Cordioli, M., additional, Soldani, F., additional, Pezzani, M.D., additional, Avallone, S., additional, Bruno, R., additional, Ricciardi, A., additional, Saggese, M.P., additional, and Malerba, G., additional
Published: 2020
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11. RAAS inhibitors are not associated with mortality in COVID-19 patients: findings from an observational multicenter study in Italy and a meta-analysis of 19 studies

Author: Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, Mussinelli, R, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abete, P, Ageno, W, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Cianfrone, S, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Cozzi, O, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fusco, F, Gentile, I, Graziani, E, Guarnieri, G, Larizza, G, Leone, A, Lio, V, Lucia, M, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Palimodde, A, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scoppettuolo, G, Scorzolini, L, Sgariglia, R, Simeone, P, Trecarichi, E, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, Iacoviello, L, De Caterina, R, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Mussinelli, Roberta, My, Ilaria, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Abete, Paolo, Ageno, Walter, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Cianfrone, Stefania, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Cozzi, Ottavia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fusco, Francesco Maria, Gentile, Ivan, Graziani, Emauele, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Lucia, Mothanje Barbara, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scoppettuolo, Giancarlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Trecarichi, Enrico Maria, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, Iacoviello, Licia, De Caterina, Raffaele, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, Mussinelli, R, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abete, P, Ageno, W, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Cianfrone, S, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Cozzi, O, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fusco, F, Gentile, I, Graziani, E, Guarnieri, G, Larizza, G, Leone, A, Lio, V, Lucia, M, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Palimodde, A, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scoppettuolo, G, Scorzolini, L, Sgariglia, R, Simeone, P, Trecarichi, E, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, Iacoviello, L, De Caterina, R, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Mussinelli, Roberta, My, Ilaria, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Abete, Paolo, Ageno, Walter, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Cianfrone, Stefania, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Cozzi, Ottavia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fusco, Francesco Maria, Gentile, Ivan, Graziani, Emauele, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Lucia, Mothanje Barbara, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scoppettuolo, Giancarlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Trecarichi, Enrico Maria, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, Iacoviello, Licia, and De Caterina, Raffaele
Abstract: Objective: The hypothesis that been set forward that use of Renin Angiotensin Aldosterone System (RAAS) inhibitors is associated with COVID-19 severity. We set-up a multicenter Italian collaboration (CORIST Project, ClinicalTrials.gov ID: NCT04318418) to retrospectively investigate the relationship between RAAS inhibitors and COVID-19 in-hospital mortality. We also carried out an updated meta-analysis on the relevant studies. Methods: We analyzed 4,069 unselected patients with laboratory-confirmed SARS-CoV-2 infection and hospitalized in 34 clinical centers in Italy from February 19, 2020 to May 23, 2020. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received angiotensin-converting-enzyme inhibitors (ACE-I) or angiotensin-receptor blockers (ARB) with patients who did not. Articles for the meta-analysis were retrieved until July 13th, 2020 by searching in web-based libraries, and data were combined using the general variance-based method. Results: Out of 4,069 COVID-19 patients, 13.5% and 13.3% received ACE-I or ARB, respectively. Use of neither ACE-I nor ARB was associated with mortality (multivariable hazard ratio (HR) adjusted also for COVID-19 treatments: 0.96, 95% confidence interval 0.77-1.20 and HR=0.89, 0.67-1.19 for ACE-I and ARB, respectively). Findings were similar restricting the analysis to hypertensive (N=2,057) patients (HR=1.00, 0.78-1.26 and HR=0.88, 0.65-1.20) or when ACE-I or ARB were considered as a single group. Results from the meta-analysis (19 studies, 29,057 COVID-19 adult patients, 9,700 with hypertension) confirmed the absence of association. Conclusions: In this observational study and meta-analysis of the literature, ACE-I or ARB use was not associated with severity or in-hospital mortality in COVID-19 patients.
Published: 2020

12. Common cardiovascular risk factors and in-hospital mortality in 3,894 patients with COVID-19: survival analysis and machine learning-based findings from the multicentre Italian CORIST Study

Author: Di Castelnuovo, A, Bonaccio, M, Costanzo, S, Gialluisi, A, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, My, I, Menicanti, L, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abdeddaim, A, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Aucella, F, Barbieri, G, Bartoloni, A, Bologna, C, Bonfanti, P, Brancati, S, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Cingolani, A, Cipollone, F, Colomba, C, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Palma, G, Di Tano, G, Fantoni, M, Filippini, T, Fioretto, P, Fusco, F, Gentile, I, Grisafi, L, Guarnieri, G, Landi, F, Larizza, G, Leone, A, Maccagni, G, Maccarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marotta, C, Marra, L, Mastroianni, F, Mengozzi, A, Menichetti, F, Milic, J, Miurri, R, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Pizzi, R, Poletti, V, Raffaelli, F, Ravaglia, C, Righetti, G, Rognoni, A, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scarafino, A, Scorzolini, L, Sgariglia, R, Simeone, P, Spinoni, E, Torti, C, Trecarichi, E, Vezzani, F, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Bonaccio, Marialaura, Costanzo, Simona, Gialluisi, Alessandro, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bruno, Raffaele, Cauda, Roberto, Guaraldi, Giovanni, My, Ilaria, Menicanti, Lorenzo, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G., Vergori, Alessandra, Abdeddaim, Amina, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Brancati, Serena, Cacciatore, Francesco, Caiano, Lucia, Cannata, Francesco, Carrozzi, Laura, Cascio, Antonio, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Crisetti, Annalisa, Crosta, Francesco, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Palma, Gisella, Di Tano, Giuseppe, Fantoni, Massimo, Filippini, Tommaso, Fioretto, Paola, Fusco, Francesco Maria, Gentile, Ivan, Grisafi, Leonardo, Guarnieri, Gabriella, Landi, Francesco, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Maccarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Miurri, Rita, Montineri, Arturo, Mussinelli, Roberta, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A., Pizzi, Roberto, Poletti, Venerino, Raffaelli, Francesca, Ravaglia, Claudia, Righetti, Giulia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scarafino, Antonio, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinoni, Enrico, Torti, Carlo, Trecarichi, Enrico Maria, Vezzani, Francesca, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Bonaccio, M, Costanzo, S, Gialluisi, A, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, My, I, Menicanti, L, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abdeddaim, A, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Aucella, F, Barbieri, G, Bartoloni, A, Bologna, C, Bonfanti, P, Brancati, S, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Cingolani, A, Cipollone, F, Colomba, C, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Palma, G, Di Tano, G, Fantoni, M, Filippini, T, Fioretto, P, Fusco, F, Gentile, I, Grisafi, L, Guarnieri, G, Landi, F, Larizza, G, Leone, A, Maccagni, G, Maccarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marotta, C, Marra, L, Mastroianni, F, Mengozzi, A, Menichetti, F, Milic, J, Miurri, R, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Pizzi, R, Poletti, V, Raffaelli, F, Ravaglia, C, Righetti, G, Rognoni, A, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scarafino, A, Scorzolini, L, Sgariglia, R, Simeone, P, Spinoni, E, Torti, C, Trecarichi, E, Vezzani, F, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Bonaccio, Marialaura, Costanzo, Simona, Gialluisi, Alessandro, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bruno, Raffaele, Cauda, Roberto, Guaraldi, Giovanni, My, Ilaria, Menicanti, Lorenzo, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G., Vergori, Alessandra, Abdeddaim, Amina, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Brancati, Serena, Cacciatore, Francesco, Caiano, Lucia, Cannata, Francesco, Carrozzi, Laura, Cascio, Antonio, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Crisetti, Annalisa, Crosta, Francesco, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Palma, Gisella, Di Tano, Giuseppe, Fantoni, Massimo, Filippini, Tommaso, Fioretto, Paola, Fusco, Francesco Maria, Gentile, Ivan, Grisafi, Leonardo, Guarnieri, Gabriella, Landi, Francesco, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Maccarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Miurri, Rita, Montineri, Arturo, Mussinelli, Roberta, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A., Pizzi, Roberto, Poletti, Venerino, Raffaelli, Francesca, Ravaglia, Claudia, Righetti, Giulia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scarafino, Antonio, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinoni, Enrico, Torti, Carlo, Trecarichi, Enrico Maria, Vezzani, Francesca, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, De Caterina, Raffaele, and Iacoviello, Licia
Abstract: Background and aims: There is poor knowledge on characteristics, comorbidities and laboratory measures associated with risk for adverse outcomes and in-hospital mortality in European Countries. We aimed at identifying baseline characteristics predisposing COVID-19 patients to in-hospital death. Methods and results: Retrospective observational study on 3894 patients with SARS-CoV-2 infection hospitalized from February 19th to May 23rd, 2020 and recruited in 30 clinical centres distributed throughout Italy. Machine learning (random forest)-based and Cox survival analysis. 61.7% of participants were men (median age 67 years), followed up for a median of 13 days. In-hospital mortality exhibited a geographical gradient, Northern Italian regions featuring more than twofold higher death rates as compared to Central/Southern areas (15.6% vs 6.4%, respectively). Machine learning analysis revealed that the most important features in death classification were impaired renal function, elevated C reactive protein and advanced age. These findings were confirmed by multivariable Cox survival analysis (hazard ratio (HR): 8.2; 95% confidence interval (CI) 4.6–14.7 for age ≥85 vs 18–44 y); HR = 4.7; 2.9–7.7 for estimated glomerular filtration rate levels <15 vs ≥ 90 mL/min/1.73 m2; HR = 2.3; 1.5–3.6 for C-reactive protein levels ≥10 vs ≤ 3 mg/L). No relation was found with obesity, tobacco use, cardiovascular disease and related-comorbidities. The associations between these variables and mortality were substantially homogenous across all sub-groups analyses. Conclusions: Impaired renal function, elevated C-reactive protein and advanced age were major predictors of in-hospital death in a large cohort of unselected patients with COVID-19, admitted to 30 different clinical centres all over Italy.
Published: 2020

13. Common cardiovascular risk factors and in-hospital mortality in 3,894 patients with COVID-19: survival analysis and machine learning-based findings from the multicentre Italian CORIST Study

Author: Di Castelnuovo, A., Bonaccio, M., Costanzo, S., Gialluisi, A., Antinori, A., Berselli, N., Blandi, L., Bruno, Rosa Anna, Cauda, Roberto, Guaraldi, G., My, I., Menicanti, L., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abdeddaim, A., Ageno, W., Agodi, A., Agostoni, P., Aiello, L., Al Moghazi, S., Aucella, F., Barbieri, G., Bartoloni, A., Bologna, C., Bonfanti, P., Brancati, S., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Cingolani, Antonella, Cipollone, F., Colomba, C., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., De Gaetano Donati, Katleen, Di Gennaro, F., Di Palma, G., Di Tano, G., Fantoni, Massimo, Filippini, T., Fioretto, P., Fusco, F. M., Gentile, I., Grisafi, L., Guarnieri, G., Landi, Francesco, Larizza, G., Leone, A., Maccagni, G., Maccarella, S., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marotta, C., Marra, L., Mastroianni, F., Mengozzi, A., Menichetti, F., Milic, J., Murri, Rita, Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Pizzi, R., Poletti, V., Raffaelli, Francesca, Ravaglia, C., Righetti, G., Rognoni, A., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scarafino, A., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinoni, E., Torti, C., Trecarichi, Enrico Maria, Vezzani, F., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., De Caterina, R., Iacoviello, L., Bruno R., Cauda R. (ORCID:0000-0002-1498-4229), Cingolani A. (ORCID:0000-0002-3793-2755), de Gaetano Donati K., Fantoni M. (ORCID:0000-0001-6913-8460), Landi F. (ORCID:0000-0002-3472-1389), Murri R. (ORCID:0000-0003-4263-7854), Raffaelli F., Trecarichi E. M., Di Castelnuovo, A., Bonaccio, M., Costanzo, S., Gialluisi, A., Antinori, A., Berselli, N., Blandi, L., Bruno, Rosa Anna, Cauda, Roberto, Guaraldi, G., My, I., Menicanti, L., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abdeddaim, A., Ageno, W., Agodi, A., Agostoni, P., Aiello, L., Al Moghazi, S., Aucella, F., Barbieri, G., Bartoloni, A., Bologna, C., Bonfanti, P., Brancati, S., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Cingolani, Antonella, Cipollone, F., Colomba, C., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., De Gaetano Donati, Katleen, Di Gennaro, F., Di Palma, G., Di Tano, G., Fantoni, Massimo, Filippini, T., Fioretto, P., Fusco, F. M., Gentile, I., Grisafi, L., Guarnieri, G., Landi, Francesco, Larizza, G., Leone, A., Maccagni, G., Maccarella, S., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marotta, C., Marra, L., Mastroianni, F., Mengozzi, A., Menichetti, F., Milic, J., Murri, Rita, Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Pizzi, R., Poletti, V., Raffaelli, Francesca, Ravaglia, C., Righetti, G., Rognoni, A., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scarafino, A., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinoni, E., Torti, C., Trecarichi, Enrico Maria, Vezzani, F., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., De Caterina, R., Iacoviello, L., Bruno R., Cauda R. (ORCID:0000-0002-1498-4229), Cingolani A. (ORCID:0000-0002-3793-2755), de Gaetano Donati K., Fantoni M. (ORCID:0000-0001-6913-8460), Landi F. (ORCID:0000-0002-3472-1389), Murri R. (ORCID:0000-0003-4263-7854), Raffaelli F., and Trecarichi E. M.
Abstract: Background and aims: There is poor knowledge on characteristics, comorbidities and laboratory measures associated with risk for adverse outcomes and in-hospital mortality in European Countries. We aimed at identifying baseline characteristics predisposing COVID-19 patients to in-hospital death. Methods and results: Retrospective observational study on 3894 patients with SARS-CoV-2 infection hospitalized from February 19th to May 23rd, 2020 and recruited in 30 clinical centres distributed throughout Italy. Machine learning (random forest)-based and Cox survival analysis. 61.7% of participants were men (median age 67 years), followed up for a median of 13 days. In-hospital mortality exhibited a geographical gradient, Northern Italian regions featuring more than twofold higher death rates as compared to Central/Southern areas (15.6% vs 6.4%, respectively). Machine learning analysis revealed that the most important features in death classification were impaired renal function, elevated C reactive protein and advanced age. These findings were confirmed by multivariable Cox survival analysis (hazard ratio (HR): 8.2; 95% confidence interval (CI) 4.6–14.7 for age ≥85 vs 18–44 y); HR = 4.7; 2.9–7.7 for estimated glomerular filtration rate levels <15 vs ≥ 90 mL/min/1.73 m2; HR = 2.3; 1.5–3.6 for C-reactive protein levels ≥10 vs ≤ 3 mg/L). No relation was found with obesity, tobacco use, cardiovascular disease and related-comorbidities. The associations between these variables and mortality were substantially homogenous across all sub-groups analyses. Conclusions: Impaired renal function, elevated C-reactive protein and advanced age were major predictors of in-hospital death in a large cohort of unselected patients with COVID-19, admitted to 30 different clinical centres all over Italy.
Published: 2020

14. Vitamin D deficiency is an independent risk factor and is predictor of infections in patients affected by HCV-related liver cirrhosis

Author: Buonomo, A.R., primary, Zappulo, E., additional, Scotto, R., additional, Pinchera, B., additional, Maraolo, A.E., additional, Borrelli, F., additional, Di Filippo, G., additional, Borgia, G., additional, and Gentile, I., additional
Published: 2017
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15. Hepatitis C screening in the emergency department of a large hospital in Southern Italy: Results of a pilot study

Author: Gentile, I., Pinchera, B., Viceconte, G., Crispo, M., Simeone, D., Riccardo Scotto, Zappulo, E., Maraolo, A. E., Paladino, F., Tortora, R., Di Costanzo, G. G., Buonomo, A. R., Borgia, G., Gentile, Ivan, Pinchera, Biagio, Viceconte, Giulio, Crispo, Manuel, Simeone, Davide, Scotto, Riccardo, Zappulo, Emanuela, Maraolo, Alberto Enrico, Paladino, Fiorella, Tortora, Raffaella, Di Costanzo, Giovanni Giuseppe, Buonomo, Antonio, and Borgia, Guglielmo
Abstract: Around 71 million people worldwide are chronically infected with hepatitis C. HCV prevalence among individuals born in the United States between 1945 and 1965 is estimated to be about 3%. In Italy, about 2% of the population is chronically infected with HCV. Since chronic HCV infection is often asymptomatic, many patients require access to medical care only in an advanced phase of the disease. The best strategy for bringing out hidden chronic HCV infection remains uncertain. The aim of the study was to evaluate the feasibility of an FDA-approved rapid salivary, point-of-care (POC) assay for anti-HCV, performed in patients aged between 45 and 80 years old who were referred to the emergency department of a large hospital in southern Italy and were all unaware of their HCV serostatus. In all, 966 patients were interviewed during the study period. Among them, 220 patients were enrolled. Notably, 25/588 (4%) reported to be anti-HCV positive. Of these, 19 were already being treated with direct-acting antivirals (DAA). Among the enrolled patients, two (0.9%) tested anti-HCV positive and 218 (99.1%) were negative at screening. Both patients with a positive test were male, below the age of 54, with a previous history of intravenous drug abuse, a low level of education, and who had had at least one experience of unprotected sex. We scheduled a visit for treatment evaluation for every positive patient who was not on treatment. Neither of the two de novo patients and 3/6 (50%) patients who were aware of their anti-HCV positivity came to the follow-up visit. Our study shows that a screening strategy for HCV infection in ED is feasible and that about 1% of patients attending the ED and who are unaware of their conditions are anti-HCV positive. Moreover, a non-negligible proportion of subjects, though aware of their condition, was not linked to any hepatologic center.

16. Low Vitamin D Levels Are Associated with the Presence of Serum Cryoglobulins in Patients with Chronic HCV Infection

Author: Gentile, I., Scarano, F., Celotti, A., Iuliis, E., Scarano, R., Granata, V., Pinchera, B., Meola, M., D Ambra, A., Piccirillo, M., Di Paola, F., Cavalcanti, E., Izzo, F., Scarpato, N., Guglielmo BORGIA, Gentile, Ivan, Scarano, Filomena, Celotti, Anna, DE Iuliis, Enrica, Scarano, Rosanna, Granata, Vincenza, Pinchera, Biagio, Meola, Mariangela, D'Ambra, Antonietta, Piccirillo, Mauro, DI Paola, Flaviano, Cavalcanti, Ernesta, Izzo, Francesco, Scarpato, Nicola, Borgia, Guglielmo, De Iuliis, Enrica, and Di Paola, Flaviano
Subjects: Pharmacology, extrahepatic manifestation, Biochemistry, Genetics and Molecular Biology (all), immune regulation, lymphoma, Hepatitis C, metabolism, low-antigen diet
Abstract: Background/aim: Mixed Cryoglobulinemia (MC) represents the most frequent extrahepatic manifestation of chronic Hepatitis C Virus (HCV) infection. Its pathogenic mechanisms involve HCV-induced chronic stimulation of B-lymphocytes. We aimed to investigate the relationship between serum levels of vitamin D (a regulator of immune response) and the presence of serum cryoglobulins in the setting of HCV infection. Patients and methods: We evaluated the serum concentration of 25(OH)vitamin D and cryoglobulins in 106 patients with chronic HCV infection. Results: Thirty patients (28.3%) showed the presence of serum cryoglobulins. For the cohort overall, the median serum 25(OH)vitamin D level was 10.95 ng/ml. Patients with serum cryoglobulins had significantly lower levels of 25(OH)vitamin D (5.61 ng/ml) than those without (13.65 ng/ml, p=0.029). At multivariate analysis, severe hypovitaminosis [i.e. 25(OH)vitamin D

17. Efficacy of the 'first wave' Direct Acting antivirals against HCV infection: Results from the Italian LINA (Liver Network Activity) cohort

Author: Gentile, I., Coppola, C., Staiano, L., Amoruso, D. C., Saturnino, M. R., Maraolo, A. E., Portunato, F., Pascalis, S., Martini, S., Crispo, M., Macera, M., Pinchera, B., Zappulo, E., Scotto, R., Coppola, N., Antonio Riccardo Buonomo, Gentile, Ivan, Buonomo, Antonio Riccardo, Coppola, Carmine, Staiano, Laura, Amoruso, Daniela Caterina, Saturnino, Maria Rosaria, Maraolo, Alberto Enrico, Portunato, Federica, De Pascalis, Stefania, Martini, Salvatore, Crispo, Manuel, Macera, Margherita, Pinchera, Biagio, Zappulo, Emanuela, Scotto, Riccardo, and Coppola, Nicola
Subjects: Antiviral Agent, Liver Cirrhosis, Male, Hepaciviru, Genotype, Hepacivirus, Hepatitis C, Chronic, Middle Aged, Antiviral Agents, Cohort Studies, Prospective Studie, Treatment Outcome, Italy, parasitic diseases, HCV, Humans, Drug Therapy, Combination, Female, real-life, Prospective Studies, Cohort Studie, DAA, Human, Aged
Abstract: Approximately 71 million people are chronically infected with HCV worldwide. Recently, interferonfree therapies effective against HCV became available and nowadays, therapeutic strategies include a combination of two or three drugs with different mechanisms of action. In the present study, we reported real-life SVR rates in a large cohort of four prescribing centers in a high-endemic area of Southern Italy. We conducted a prospective multicenter study among all the patients with chronic HCV infection, who received therapy with the first available interferon-free therapies between March 2015 and December 2017 and who referred to one of the 4 DAA-prescribing centers in Campania, Southern Italy. Patients with Child C cirrhosis, a diagnosis of active HCC at the baseline or who refused the consent form, were excluded. Nine-hundred fifty-three patients were enrolled. Most of the enrolled patients had HCV genotype 1b infection (66.4%), were older than 65 years (64.1%) and had advanced liver fibrosis (Metavir > F4) (73.5%). The overall SVR12 rate was 98.5%. Patients with clinical cirrhosis had a similar SVR12 rate compared with those without cirrhosis (97.8% vs 99.2%, p=0.09), while patients with decompensated cirrhosis had a significantly lower rate of SVR12 compared with those without decompensated disease (95.3% vs 99.0%, p65 years, those with clinical cirrhosis, as well as those with advanced liver fibrosis, had a similar SVR12 rate compared with the patients with a Metavir score < F4 (98.3% vs 99.0%, p=0.70 and 98.6% vs 98.6%, p=1.00, respectively). In the present, real-life study, DAA regimens are effective and safe in patients with chronic HCV infection, regardless of age and stage of liver disease, providing very high rates of SVR12 (98.5%).

18. Heparin in COVID-19 patients is associated with reduced in-hospital mortality: the multicentre Italian CORIST Study

Author: Walter Ageno, Raffaele Pesavento, Marinella Astuto, Katleen de Gaetano Donati, Francesca Santilli, Filippo Aucella, Eleonora Taddei, Marianna Meschiari, Laura Scorzolini, Biagio Pinchera, Giustino Parruti, Licia Iacoviello, Andrea Vianello, Gabriella Guarnieri, Arturo Montineri, Crizia Colombo, Carlo Signorelli, Lorenzo Blandi, Raffaele De Caterina, Maria Musso, Francesco Petri, Stefano Maitan, Anna Odone, Lucia Caiano, Francesca Crosta, Lorenzo Marra, Giuseppe Patti, Emanuela Pasi, Jovana Milic, Marco Olivieri, Claudia Colomba, Francesco Maria Fusco, Claudia Ravaglia, Alexandra Virano, Carlo Torti, Samir Al Moghazi, Venerino Poletti, Riccardo Maragna, Carlo Sanrocco, Sandro Mancarella, Greta Barbieri, Arturo Ciccullo, Leonardo Grisafi, Paola Simeone, Lorenzo Menicanti, Antonella Palimodde, Gloria Maccagni, Alessandra Vergori, Daniela Niola, Marco G. Mennuni, Gianpiero D'Offizi, Claudia Marotta, Damiano D'Ardes, Vincenzo Sangiovanni, Paolo Bonfanti, Giovanni Larizza, Francesco Di Gennaro, Alessandro Mengozzi, Massimo Mapelli, Giuseppe Di Tano, Laura Carrozzi, Antonella Agodi, Francesco Menichetti, Marialaura Bonaccio, Andrea Antinori, Marco Vinceti, Armando Leone, Franco Mastroianni, Silvia Marongiu, Filippo Minutolo, Giulio Maresca, Beatrice Molena, Nausicaa Berselli, Francesco Cipollone, Massimo Fantoni, Antonella Cingolani, Giovanni Guaraldi, Raffaella Sgariglia, Piergiuseppe Agostoni, Antonio Cascio, Maria Mazzitelli, Roberta Parisi, Augusto Di Castelnuovo, Gian Battista Danzi, Luca Aiello, Roberto Vettor, Elvira Grandone, Laura Vocciante, Emauele Graziani, Cristina Mussini, Marianna Rossi, Marco Rossato, Roberto Cauda, Rosa Arboretti, Alessandro Bartoloni, Simona Costanzo, Francesco Gianfagna, Andrea Rognoni, Ferruccio Madaro, Rossella Marcucci, Pasquale Abete, Francesco Cacciatore, Ivan Gentile, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Danzi, G. B, De Gaetano Donati, K, Fusco, F. M, Simeone, P. G, Iacoviello, L., Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo A., Costanzo S., Antinori A., Berselli N., Blandi L., Bonaccio M., Cauda R., Guaraldi G., Menicanti L., Mennuni M., Parruti G., Patti G., Santilli F., Signorelli C., Vergori A., Abete P., Ageno W., Agodi A., Agostoni P., Aiello L., Al Moghazi S., Arboretti R., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonfanti P., Cacciatore F., Caiano L., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Colombo C., Crosta F., Danzi G.B., D'Ardes D., De Gaetano Donati K., Di Gennaro F., Di Tano G., D'Offizi G., Fantoni M., Fusco F.M., Gentile I., Gianfagna F., Grandone E., Graziani E., Grisafi L., Guarnieri G., Larizza G., Leone A., MacCagni G., Madaro F., Maitan S., Mancarella S., Mapelli M., Maragna R., Marcucci R., Maresca G., Marongiu S., Marotta C., Marra L., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Milic J., Minutolo F., Molena B., Montineri A., Mussini C., Musso M., Niola D., Odone A., Olivieri M., Palimodde A., Parisi R., Pasi E., Pesavento R., Petri F., Pinchera B., Poletti V., Ravaglia C., Rognoni A., Rossato M., Rossi M., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Taddei E., Torti C., Vettor R., Vianello A., Vinceti M., Virano A., Vocciante L., De Caterina R., and Iacoviello L.
Subjects: Male, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, coronavirus, heparin, 030204 cardiovascular system & hematology, Lower risk, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Clinical endpoint, medicine, Humans, Thrombophilia, 030212 general & internal medicine, Hospital Mortality, Blood Coagulation, Survival analysis, Aged, Retrospective Studies, treatment, business.industry, Heparin, Mortality rate, COVID-19,mortality, Low-Molecular-Weight, Anticoagulants, COVID-19, Retrospective cohort study, Hematology, Heparin, Low-Molecular-Weight, Middle Aged, mortality, Survival Analysis, COVID-19 Drug Treatment, coagulation activation, coronaviru, Italy, treatments, Propensity score matching, Female, business, medicine.drug
Abstract: Introduction A hypercoagulable condition was described in patients with coronavirus disease 2019 (COVID-19) and proposed as a possible pathogenic mechanism contributing to disease progression and lethality. Aim We evaluated if in-hospital administration of heparin improved survival in a large cohort of Italian COVID-19 patients. Methods In a retrospective observational study, 2,574 unselected patients hospitalized in 30 clinical centers in Italy from February 19, 2020 to June 5, 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus-2 infection were analyzed. The primary endpoint in a time-to event analysis was in-hospital death, comparing patients who received heparin (low-molecular-weight heparin [LMWH] or unfractionated heparin [UFH]) with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores. Results Out of 2,574 COVID-19 patients, 70.1% received heparin. LMWH was largely the most used formulation (99.5%). Death rates for patients receiving heparin or not were 7.4 and 14.0 per 1,000 person-days, respectively. After adjustment for propensity scores, we found a 40% lower risk of death in patients receiving heparin (hazard ratio = 0.60; 95% confidence interval: 0.49–0.74; E-value = 2.04). This association was particularly evident in patients with a higher severity of disease or strong coagulation activation. Conclusion In-hospital heparin treatment was associated with a lower mortality, particularly in severely ill COVID-19 patients and in those with strong coagulation activation. The results from randomized clinical trials are eagerly awaited to provide clear-cut recommendations.
Published: 2021
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19. Lopinavir/ritonavir and darunavir/cobicistat in hospitalized covid-19 patients: Findings from the multicenter italian corist study

Author: Augusto Di Castelnuovo, Simona Costanzo, Andrea Antinori, Nausicaa Berselli, Lorenzo Blandi, Marialaura Bonaccio, Raffaele Bruno, Roberto Cauda, Alessandro Gialluisi, Giovanni Guaraldi, Lorenzo Menicanti, Marco Mennuni, Ilaria My, Agostino Parruti, Giuseppe Patti, Stefano Perlini, Francesca Santilli, Carlo Signorelli, Giulio G. Stefanini, Alessandra Vergori, Walter Ageno, Luca Aiello, Piergiuseppe Agostoni, Samir Al Moghazi, Rosa Arboretti, Filippo Aucella, Greta Barbieri, Martina Barchitta, Alessandro Bartoloni, Carolina Bologna, Paolo Bonfanti, Lucia Caiano, Laura Carrozzi, Antonio Cascio, Giacomo Castiglione, Mauro Chiarito, Arturo Ciccullo, Antonella Cingolani, Francesco Cipollone, Claudia Colomba, Crizia Colombo, Francesco Crosta, Giovanni Dalena, Chiara Dal Pra, Gian Battista Danzi, Damiano D'Ardes, Katleen de Gaetano Donati, Francesco Di Gennaro, Giuseppe Di Tano, Gianpiero D'Offizi, Tommaso Filippini, Francesco Maria Fusco, Carlo Gaudiosi, Ivan Gentile, Giancarlo Gini, Elvira Grandone, Gabriella Guarnieri, Gennaro L. F. Lamanna, Giovanni Larizza, Armando Leone, Veronica Lio, Angela Raffaella Losito, Gloria Maccagni, Stefano Maitan, Sandro Mancarella, Rosa Manuele, Massimo Mapelli, Riccardo Maragna, Lorenzo Marra, Giulio Maresca, Claudia Marotta, Franco Mastroianni, Maria Mazzitelli, Alessandro Mengozzi, Francesco Menichetti, Jovana Milic, Filippo Minutolo, Beatrice Molena, R. Mussinelli, Cristina Mussini, Maria Musso, Anna Odone, Marco Olivieri, Emanuela Pasi, Annalisa Perroni, Francesco Petri, Biagio Pinchera, Carlo A. Pivato, Venerino Poletti, Claudia Ravaglia, Marco Rossato, Marianna Rossi, Anna Sabena, Francesco Salinaro, Vincenzo Sangiovanni, Carlo Sanrocco, Laura Scorzolini, Raffaella Sgariglia, Paola Giustina Simeone, Michele Spinicci, Enrico Maria Trecarichi, Giovanni Veronesi, Roberto Vettor, Andrea Vianello, Marco Vinceti, Elena Visconti, Laura Vocciante, Raffaele De Caterina, Licia Iacoviello, The COVID-19 RISK and Treatments (CORIST) Collaboration, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Bruno, Raffaele, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, My, Ilaria, Parruti, Agostino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Ageno, Walter, Aiello, Luca, Agostoni, Piergiuseppe, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Chiarito, Mauro, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesco, Dalena, Giovanni, Dal Pra, Chiara, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Filippini, Tommaso, Maria Fusco, Francesco, Gaudiosi, Carlo, Gentile, Ivan, Gini, Giancarlo, Grandone, Elvira, Guarnieri, Gabriella, Lamanna, Gennaro L F, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Losito, Angela Raffaella, Maccagni, Gloria, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marra, Lorenzo, Maresca, Giulio, Marotta, Claudia, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussinelli, R, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Perroni, Annalisa, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Spinicci, Michele, Trecarichi, Enrico Maria, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Visconti, Elena, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Bruno, R, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, My, I, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Ageno, W, Aiello, L, Agostoni, P, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bologna, C, Bonfanti, P, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Chiarito, M, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Dalena, G, Dal Pra, C, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Filippini, T, Maria Fusco, F, Gaudiosi, C, Gentile, I, Gini, G, Grandone, E, Guarnieri, G, Lamanna, G, Larizza, G, Leone, A, Lio, V, Losito, A, Maccagni, G, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Perroni, A, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Visconti, E, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, A., Costanzo, S., Antinori, A., Berselli, N., Blandi, L., Bonaccio, M., Bruno, R., Cauda, R., Gialluisi, A., Guaraldi, G., Menicanti, L., Mennuni, M., My, I., Parruti, A., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Ageno, W., Aiello, L., Agostoni, P., Moghazi, S. A., Arboretti, R., Aucella, F., Barbieri, G., Barchitta, M., Bartoloni, A., Bologna, C., Bonfanti, P., Caiano, L., Carrozzi, L., Cascio, A., Castiglione, G., Chiarito, M., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Colombo, C., Crosta, F., Dalena, G., Dal Pra, C., Danzi, G. B., D'Ardes, D., Donati, K. G., Di Gennaro, F., Di Tano, G., D'Offizi, G., Filippini, T., Fusco, F. M., Gaudiosi, C., Gentile, I., Gini, G., Grandone, E., Guarnieri, G., Lamanna, G. L. F., Larizza, G., Leone, A., Lio, V., Losito, A. R., Maccagni, G., Maitan, S., Mancarella, S., Manuele, R., Mapelli, M., Maragna, R., Marra, L., Maresca, G., Marotta, C., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Milic, J., Minutolo, F., Molena, B., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Perroni, A., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinicci, M., Trecarichi, E. M., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., Visconti, E., Vocciante, L., Caterina, R. D., Iacoviello, L., Di Castelnuovo A., Costanzo S., Antinori A., Berselli N., Blandi L., Bonaccio M., Bruno R., Cauda R., Gialluisi A., Guaraldi G., Menicanti L., Mennuni M., My I., Parruti A., Patti G., Perlini S., Santilli F., Signorelli C., Stefanini G.G., Vergori A., Ageno W., Aiello L., Agostoni P., Moghazi S.A., Arboretti R., Aucella F., Barbieri G., Barchitta M., Bartoloni A., Bologna C., Bonfanti P., Caiano L., Carrozzi L., Cascio A., Castiglione G., Chiarito M., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Colombo C., Crosta F., Dalena G., Dal Pra C., Danzi G.B., D'ardes D., Donati K.G., Di Gennaro F., Di Tano G., D'offizi G., Filippini T., Fusco F.M., Gaudiosi C., Gentile I., Gini G., Grandone E., Guarnieri G., Lamanna G.L.F., Larizza G., Leone A., Lio V., Losito A.R., Maccagni G., Maitan S., Mancarella S., Manuele R., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Milic J., Minutolo F., Molena B., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Perroni A., Petri F., Pinchera B., Pivato C.A., Poletti V., Ravaglia C., Rossato M., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Spinicci M., Trecarichi E.M., Veronesi G., Vettor R., Vianello A., Vinceti M., Visconti E., Vocciante L., Caterina R.D., and Iacoviello L.
Subjects: Medicine (General), medicine.medical_specialty, Lopinavir/ritonavir, Lopinavir, R5-920, Internal medicine, medicine, Darunavir, Original Research, COVID-19, In-hospital mortality, SARS-CoV-2, darunavir, in-hospital mortality, lopinavir, business.industry, Cobicistat, Mortality rate, General Medicine, medicine.disease, Propensity score matching, Medicine, Ritonavir, business, medicine.drug, Kidney disease
Abstract: Background: Protease inhibitors have been considered as possible therapeutic agents for COVID-19 patients.Objectives: To describe the association between lopinavir/ritonavir (LPV/r) or darunavir/cobicistat (DRV/c) use and in-hospital mortality in COVID-19 patients.Study Design: Multicenter observational study of COVID-19 patients admitted in 33 Italian hospitals. Medications, preexisting conditions, clinical measures, and outcomes were extracted from medical records. Patients were retrospectively divided in three groups, according to use of LPV/r, DRV/c or none of them. Primary outcome in a time-to event analysis was death. We used Cox proportional-hazards models with inverse probability of treatment weighting by multinomial propensity scores.Results: Out of 3,451 patients, 33.3% LPV/r and 13.9% received DRV/c. Patients receiving LPV/r or DRV/c were more likely younger, men, had higher C-reactive protein levels while less likely had hypertension, cardiovascular, pulmonary or kidney disease. After adjustment for propensity scores, LPV/r use was not associated with mortality (HR = 0.94, 95% CI 0.78 to 1.13), whereas treatment with DRV/c was associated with a higher death risk (HR = 1.89, 1.53 to 2.34, E-value = 2.43). This increased risk was more marked in women, in elderly, in patients with higher severity of COVID-19 and in patients receiving other COVID-19 drugs.Conclusions: In a large cohort of Italian patients hospitalized for COVID-19 in a real-life setting, the use of LPV/r treatment did not change death rate, while DRV/c was associated with increased mortality. Within the limits of an observational study, these data do not support the use of LPV/r or DRV/c in COVID-19 patients.
Published: 2021

20. Common cardiovascular risk factors and in-hospital mortality in 3,894 patients with COVID-19: survival analysis and machine learning-based findings from the multicentre Italian CORIST Study

Author: Augusto Di Castelnuovo, Marialaura Bonaccio, Simona Costanzo, Alessandro Gialluisi, Andrea Antinori, Nausicaa Berselli, Lorenzo Blandi, Raffaele Bruno, Roberto Cauda, Giovanni Guaraldi, Ilaria My, Lorenzo Menicanti, Giustino Parruti, Giuseppe Patti, Stefano Perlini, Francesca Santilli, Carlo Signorelli, Giulio G. Stefanini, Alessandra Vergori, Amina Abdeddaim, Walter Ageno, Antonella Agodi, Piergiuseppe Agostoni, Luca Aiello, Samir Al Moghazi, Filippo Aucella, Greta Barbieri, Alessandro Bartoloni, Carolina Bologna, Paolo Bonfanti, Serena Brancati, Francesco Cacciatore, Lucia Caiano, Francesco Cannata, Laura Carrozzi, Antonio Cascio, Antonella Cingolani, Francesco Cipollone, Claudia Colomba, Annalisa Crisetti, Francesca Crosta, Gian B. Danzi, Damiano D'Ardes, Katleen de Gaetano Donati, Francesco Di Gennaro, Gisella Di Palma, Giuseppe Di Tano, Massimo Fantoni, Tommaso Filippini, Paola Fioretto, Francesco M. Fusco, Ivan Gentile, Leonardo Grisafi, Gabriella Guarnieri, Francesco Landi, Giovanni Larizza, Armando Leone, Gloria Maccagni, Sandro Maccarella, Massimo Mapelli, Riccardo Maragna, Rossella Marcucci, Giulio Maresca, Claudia Marotta, Lorenzo Marra, Franco Mastroianni, Alessandro Mengozzi, Francesco Menichetti, Jovana Milic, Rita Murri, Arturo Montineri, Roberta Mussinelli, Cristina Mussini, Maria Musso, Anna Odone, Marco Olivieri, Emanuela Pasi, Francesco Petri, Biagio Pinchera, Carlo A. Pivato, Roberto Pizzi, Venerino Poletti, Francesca Raffaelli, Claudia Ravaglia, Giulia Righetti, Andrea Rognoni, Marco Rossato, Marianna Rossi, Anna Sabena, Francesco Salinaro, Vincenzo Sangiovanni, Carlo Sanrocco, Antonio Scarafino, Laura Scorzolini, Raffaella Sgariglia, Paola G. Simeone, Enrico Spinoni, Carlo Torti, Enrico M. Trecarichi, Francesca Vezzani, Giovanni Veronesi, Roberto Vettor, Andrea Vianello, Marco Vinceti, Raffaele De Caterina, Licia Iacoviello, Di Castelnuovo, A., Bonaccio, M., Costanzo, S., Gialluisi, A., Antinori, A., Berselli, N., Blandi, L., Bruno, R., Cauda, R., Guaraldi, G., My, I., Menicanti, L., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abdeddaim, A., Ageno, W., Agodi, A., Agostoni, P., Aiello, L., Al Moghazi, S., Aucella, F., Barbieri, G., Bartoloni, A., Bologna, C., Bonfanti, P., Brancati, S., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Cingolani, A., Cipollone, F., Colomba, C., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., de Gaetano Donati, K., Di Gennaro, F., Di Palma, G., Di Tano, G., Fantoni, M., Filippini, T., Fioretto, P., Fusco, F. M., Gentile, I., Grisafi, L., Guarnieri, G., Landi, F., Larizza, G., Leone, A., Maccagni, G., Maccarella, S., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marotta, C., Marra, L., Mastroianni, F., Mengozzi, A., Menichetti, F., Milic, J., Murri, R., Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Pizzi, R., Poletti, V., Raffaelli, F., Ravaglia, C., Righetti, G., Rognoni, A., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scarafino, A., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinoni, E., Torti, C., Trecarichi, E. M., Vezzani, F., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., De Caterina, R., Iacoviello, L., Di Castelnuovo, Augusto, Bonaccio, Marialaura, Costanzo, Simona, Gialluisi, Alessandro, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bruno, Raffaele, Cauda, Roberto, Guaraldi, Giovanni, My, Ilaria, Menicanti, Lorenzo, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G, Vergori, Alessandra, Abdeddaim, Amina, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bologna, Carolina, Bonfanti, Paolo, Brancati, Serena, Cacciatore, Francesco, Caiano, Lucia, Cannata, Francesco, Carrozzi, Laura, Cascio, Antonio, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian B, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Palma, Gisella, Di Tano, Giuseppe, Fantoni, Massimo, Filippini, Tommaso, Fioretto, Paola, Fusco, Francesco M, Gentile, Ivan, Grisafi, Leonardo, Guarnieri, Gabriella, Landi, Francesco, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Maccarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mengozzi, Alessandro, Menichetti, Francesco, Milic, Jovana, Murri, Rita, Montineri, Arturo, Mussinelli, Roberta, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Pasi, Emanuela, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A, Pizzi, Roberto, Poletti, Venerino, Raffaelli, Francesca, Ravaglia, Claudia, Righetti, Giulia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scarafino, Antonio, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola G, Spinoni, Enrico, Torti, Carlo, Trecarichi, Enrico M, Vezzani, Francesca, Veronesi, Giovanni, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Bonaccio, M, Costanzo, S, Gialluisi, A, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, My, I, Menicanti, L, Parruti, A, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abdeddaim, A, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Aucella, F, Barbieri, G, Bartoloni, A, Bologna, C, Bonfanti, P, Brancati, S, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Cingolani, A, Cipollone, F, Colomba, C, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Palma, G, Di Tano, G, Fantoni, M, Filippini, T, Fioretto, P, Fusco, F, Gentile, I, Grisafi, L, Guarnieri, G, Landi, F, Larizza, G, Leone, A, Maccagni, G, Maccarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marotta, C, Marra, L, Mastroianni, F, Mengozzi, A, Menichetti, F, Milic, J, Miurri, R, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Pizzi, R, Poletti, V, Raffaelli, F, Ravaglia, C, Righetti, G, Rognoni, A, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scarafino, A, Scorzolini, L, Sgariglia, R, Simeone, P, Spinoni, E, Torti, C, Trecarichi, E, Vezzani, F, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, De Caterina, R, and Iacoviello, L
Subjects: Male, Epidemiology, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), 030204 cardiovascular system & hematology, computer.software_genre, Machine Learning, 0302 clinical medicine, Retrospective Studie, Risk Factors, Cardiovascular Disease, 80 and over, Medicine, Age Factor, Viral, Hospital Mortality, Betacoronavirus Hospital Mortality, Young adult, Aged, 80 and over, Nutrition and Dietetics, COVID-19, In-hospital mortality, Risk factors, Mortality rate, Hazard ratio, Age Factors, Middle Aged, C-Reactive Protein, Cardiovascular Diseases, Female, Survival Analysi, Cardiology and Cardiovascular Medicine, Coronavirus Infections, Human, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Adolescent, Pneumonia, Viral, 030209 endocrinology & metabolism, Settore MED/17 - MALATTIE INFETTIVE, Machine learning, Aged, Humans, Pandemics, Retrospective Studies, SARS-CoV-2, Survival Analysis, Young Adult, Betacoronavirus, Article, 03 medical and health sciences, Risk factor, Survival analysis, Pandemic, Betacoronaviru, business.industry, Coronavirus Infection, Risk Factor, Retrospective cohort study, Pneumonia, Confidence interval, Artificial intelligence, business, computer
Abstract: Background and aims There is poor knowledge on characteristics, comorbidities and laboratory measures associated with risk for adverse outcomes and in-hospital mortality in European Countries. We aimed at identifying baseline characteristics predisposing COVID-19 patients to in-hospital death. Methods and results Retrospective observational study on 3894 patients with SARS-CoV-2 infection hospitalized from February 19th to May 23rd, 2020 and recruited in 30 clinical centres distributed throughout Italy. Machine learning (random forest)-based and Cox survival analysis. 61.7% of participants were men (median age 67 years), followed up for a median of 13 days. In-hospital mortality exhibited a geographical gradient, Northern Italian regions featuring more than twofold higher death rates as compared to Central/Southern areas (15.6% vs 6.4%, respectively). Machine learning analysis revealed that the most important features in death classification were impaired renal function, elevated C reactive protein and advanced age. These findings were confirmed by multivariable Cox survival analysis (hazard ratio (HR): 8.2; 95% confidence interval (CI) 4.6–14.7 for age ≥85 vs 18–44 y); HR = 4.7; 2.9–7.7 for estimated glomerular filtration rate levels, Highlights • Impaired renal function, elevated C-reactive protein and advanced age were major indicators of death in COVID-19 patients. • These associations were substantially homogenous across all sub-groups analysed. • No relation was found with obesity, tobacco use, cardiovascular disease and related-comorbidities. • Death rates were higher in the Northern as opposed to Central-Southern Italian regions.
Published: 2020

21. Use of hydroxychloroquine in hospitalised COVID-19 patients is associated with reduced mortality: Findings from the observational multicentre Italian CORIST study

Author: Venerino Poletti, Damiano D'Ardes, Paola Simeone, Cristina Mussini, Giustino Parruti, Sandro Maccarella, Licia Iacoviello, Giulio G. Stefanini, Roberta Mussinelli, Vincenzo Sangiovanni, Paolo Bonfanti, Roberto Vettor, Andrea Vianello, Arturo Montineri, Roberto Cauda, Elvira Grandone, Maria Mazzitelli, Claudia Ravaglia, Marialaura Bonaccio, Giulio Maresca, Francesco Di Gennaro, Alessandro Mengozzi, Anna Sabena, Gian Battista Danzi, Giuseppe Di Tano, Emanuela Pasi, Ilaria Rossi, Lucia Caiano, Laura Carrozzi, Francesco Landi, Francesca Crosta, Tommaso Filippini, Francesco Menichetti, Piergiuseppe Agostoni, Andrea Madaro, Antonio Cascio, Carlo Signorelli, Michele Spinicci, Carlo Sanrocco, Enrico Guido Spinoni, Maria Musso, Alessandra Vergori, Lorenzo Marra, Giuseppe Patti, Laura Vocciante, Marco Olivieri, Francesca Santilli, Stefano Perlini, Claudia Colomba, Francesco Salinaro, Marianna Meschiari, Gabriella Guarnieri, Giampiero D'Offizi, Riccardo Maragna, Paola Del Giacomo, Giancarlo Gini, Katleen de Gaetano Donati, Andrea Antinori, Filippo Aucella, Raffaele De Caterina, Lorenzo Menicanti, Gloria Maccagni, Amedeo Venezia, Chiara Dal Pra, Carlo Andrea Pivato, Walter Ageno, Antonella Agodi, Francesco Cannata, Francesco Petri, Luca Aiello, Biagio Pinchera, Marinella Astuto, Raffaella Sgariglia, Giovanni Guaraldi, Marco Vinceti, Laura Scorzolini, Samir Al Moghazi, Armando Leone, Giovanni Veronesi, Arturo Ciccullo, Leonardo Grisafi, Francesco Cipollone, Massimo Mapelli, Greta Barbieri, Silvia Lamonica, Raffaele Bruno, Filippo Minutolo, Antonella Cingolani, Alessandro Gialluisi, Marco Rossato, Andrea Rognoni, Marianna Rossi, Claudia Marotta, Franco Mastroianni, Ilaria My, Enrico Maria Trecarichi, Anna Odone, Alessandro Bartoloni, Simona Costanzo, Francesco Cacciatore, Ivan Gentile, Massimo Rinaldi, Nausicaa Berselli, Francesco Maria Fusco, Augusto Di Castelnuovo, Lorenzo Blandi, Castelnuovo A.D., Costanzo S., Antinori A., Berselli N., Blandi L., Bruno R., Cauda R., Guaraldi G., Menicanti L., My I., Parruti G., Patti G., Perlini S., Santilli F., Signorelli C., Spinoni E., Stefanini G.G., Vergori A., Ageno W., Agodi A., Aiello L., Agostoni P., Moghazi S.A., Astuto M., Aucella F., Barbieri G., Bartoloni A., Bonaccio M., Bonfanti P., Cacciatore F., Caiano L., Cannata F., Carrozzi L., Cascio A., Ciccullo A., Cingolani A., Cipollone F., Colomba C., Crosta F., Pra C.D., Danzi G.B., D'Ardes D., Donati K.D.G., Giacomo P.D., Gennaro F.D., Di Tano G., D'Offizi G., Filippini T., Fusco F.M., Gentile I., Gialluisi A., Gini G., Grandone E., Grisafi L., Guarnieri G., Lamonica S., Landi F., Leone A., Maccagni G., Maccarella S., Madaro A., Mapelli M., Maragna R., Marra L., Maresca G., Marotta C., Mastroianni F., Mazzitelli M., Mengozzi A., Menichetti F., Meschiari M., Minutolo F., Montineri A., Mussinelli R., Mussini C., Musso M., Odone A., Olivieri M., Pasi E., Petri F., Pinchera B., Pivato C.A., Poletti V., Ravaglia C., Rinaldi M., Rognoni A., Rossato M., Rossi I., Rossi M., Sabena A., Salinaro F., Sangiovanni V., Sanrocco C., Scorzolini L., Sgariglia R., Simeone P.G., Spinicci M., Trecarichi E.M., Venezia A., Veronesi G., Vettor R., Vianello A., Vinceti M., Vocciante L., De Caterina R., Iacoviello L., Castelnuovo, A. D., Costanzo, S., Antinori, A., Berselli, N., Blandi, L., Bruno, R., Cauda, R., Guaraldi, G., Menicanti, L., My, I., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Spinoni, E., Stefanini, G. G., Vergori, A., Ageno, W., Agodi, A., Aiello, L., Agostoni, P., Moghazi, S. A., Astuto, M., Aucella, F., Barbieri, G., Bartoloni, A., Bonaccio, M., Bonfanti, P., Cacciatore, F., Caiano, L., Cannata, F., Carrozzi, L., Cascio, A., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Crosta, F., Pra, C. D., Danzi, G. B., D'Ardes, D., Donati, K. D. G., Giacomo, P. D., Gennaro, F. D., Di Tano, G., D'Offizi, G., Filippini, T., Fusco, F. M., Gentile, I., Gialluisi, A., Gini, G., Grandone, E., Grisafi, L., Guarnieri, G., Lamonica, S., Landi, F., Leone, A., Maccagni, G., Maccarella, S., Madaro, A., Mapelli, M., Maragna, R., Marra, L., Maresca, G., Marotta, C., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Meschiari, M., Minutolo, F., Montineri, A., Mussinelli, R., Mussini, C., Musso, M., Odone, A., Olivieri, M., Pasi, E., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rinaldi, M., Rognoni, A., Rossato, M., Rossi, I., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scorzolini, L., Sgariglia, R., Simeone, P. G., Spinicci, M., Trecarichi, E. M., Venezia, A., Veronesi, G., Vettor, R., Vianello, A., Vinceti, M., Vocciante, L., De Caterina, R., Iacoviello, L., Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bruno, R, Cauda, R, Guaraldi, G, Menicanti, L, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Spinoni, E, Stefanini, G, Vergori, A, Ageno, W, Agodi, A, Aiello, L, Agostoni, P, Moghazi, S, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonaccio, M, Bonfanti, P, Cacciatore, F, Caiano, L, Cannata, F, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Crosta, F, Pra, C, Danzi, G, D'Ardes, D, Donati, K, Giacomo, P, Gennaro, F, Tano, G, D'Offizi, G, Filippini, T, Fusco, F, Gentile, I, Gialluisi, A, Gini, G, Grandone, E, Grisafi, L, Guarnieri, G, Lamonica, S, Landi, F, Leone, A, Maccagni, G, Maccarella, S, Madaro, A, Mapelli, M, Maragna, R, Marra, L, Maresca, G, Marotta, C, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Minutolo, F, Montineri, A, Mussinelli, R, Mussini, C, Musso, M, Odone, A, Olivieri, M, Pasi, E, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rinaldi, M, Rognoni, A, Rossato, M, Rossi, I, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Spinicci, M, Trecarichi, E, Venezia, A, Veronesi, G, Vettor, R, Vianello, A, Vinceti, M, Vocciante, L, De Caterina, R, and Iacoviello, L
Subjects: Male, medicine.medical_specialty, 030204 cardiovascular system & hematology, Lower risk, law.invention, COVID-19, Disease severity, Hydroxychloroquine, Inflammation, Mortality, Aged, Aged, 80 and over, Female, Hospital Mortality, Humans, Italy, Middle Aged, Retrospective Studies, Treatment Outcome, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Retrospective Studie, law, Internal medicine, 80 and over, Internal Medicine, medicine, 030212 general & internal medicine, Risk factor, business.industry, Mortality rate, Retrospective cohort study, COVID-19 Drug Treatment, Propensity score matching, Commentary, Observational study, business, Human, medicine.drug
Abstract: Background Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19. Objective We set-up a multicenter Italian collaboration to investigate the relationship between HCQ therapy and COVID-19 in-hospital mortality. Methods In a retrospective observational study, 3,451 unselected patients hospitalized in 33 clinical centers in Italy, from February 19, 2020 to May 23, 2020, with laboratory-confirmed SARS-CoV-2 infection, were analyzed. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received HCQ with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores, with the addition of subgroup analyses. Results Out of 3,451 COVID-19 patients, 76.3% received HCQ. Death rates (per 1,000 person-days) for patients receiving or not HCQ were 8.9 and 15.7, respectively. After adjustment for propensity scores, we found 30% lower risk of death in patients receiving HCQ (HR=0.70; 95%CI: 0.59 to 0.84; E-value=1.67). Secondary analyses yielded similar results. The inverse association of HCQ with inpatient mortality was particularly evident in patients having elevated C-reactive protein at entry. Conclusions HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients. Within the limits of an observational study and awaiting results from randomized controlled trials, these data do not discourage the use of HCQ in inpatients with COVID-19.
Published: 2020

22. RAAS inhibitors are not associated with mortality in COVID-19 patients: Findings from an observational multicenter study in Italy and a meta-analysis of 19 studies

Author: Francesca Santilli, Marianna Meschiari, Gabriella Guarnieri, Francesco Petri, Anna Sabena, Gloria Maccagni, Giovanni Larizza, Massimo Mapelli, Maria Mazzitelli, Gian Battista Danzi, Katleen de Gaetano Donati, Annalisa Crisetti, Jovana Milic, Raffaele Pesavento, Biagio Pinchera, Riccardo Maragna, Carlo Andrea Pivato, Lorenzo Menicanti, Francesco Maria Fusco, Luca Aiello, Sandro Mancarella, Carlo Sanrocco, Alessandra Vergori, Greta Barbieri, Filippo Aucella, Silvia Marongiu, Giulio Maresca, Marianna Rossi, Andrea Antinori, Venerino Poletti, Francesco Cacciatore, Giacomo Castiglione, Enrico Maria Trecarichi, Lucia Caiano, Francesca Crosta, Roberto Vettor, Francesco Menichetti, Maria Musso, Francesco Salinaro, Marco Olivieri, Stefano Perlini, Claudia Colomba, Crizia Colombo, Ottavia Cozzi, Stefano Maitan, Marialaura Bonaccio, Ilaria My, Alexandra Virano, Paola Simeone, Marco Vinceti, Antonella Cingolani, Gianpiero D'Offizi, Damiano D'Ardes, Claudia Marotta, M. B. Lucia, Carlo Signorelli, Lorenzo Marra, Giuseppe Patti, Raffaele De Caterina, Armando Leone, Veronica Lio, Beatrice Molena, Giustino Parruti, Giulio G. Stefanini, Licia Iacoviello, Laura Vocciante, Franco Mastroianni, Raffaella Sgariglia, Cristina Mussini, Francesco Cipollone, Marco Rossato, Lorenzo Blandi, Emanuela Pasi, Samir Al Moghazi, Andrea Vianello, Filippo Minutolo, Ivan Gentile, Giovanni Guaraldi, Rosa Manuele, Pasquale Abete, Arturo Ciccullo, Antonella Palimodde, Giancarlo Scoppettuolo, Walter Ageno, Marco G. Mennuni, Roberta Mussinelli, Vincenzo Sangiovanni, Roberto Cauda, Laura Scorzolini, Paolo Bonfanti, Alessandro Gialluisi, Stefania Cianfrone, Piergiuseppe Agostoni, Antonio Cascio, Simona Costanzo, Augusto Di Castelnuovo, Nausicaa Berselli, Rosa Arboretti, Emauele Graziani, Martina Barchitta, Anna Odone, Francesco Di Gennaro, Alessandro Mengozzi, Alessandro Bartoloni, Giuseppe Di Tano, Laura Carrozzi, Ferruccio Madaro, Rossella Marcucci, Claudia Ravaglia, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Gialluisi, Alessandro, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Mussinelli, Roberta, My, Ilaria, Parruti, Giustino, Patti, Giuseppe, Perlini, Stefano, Santilli, Francesca, Signorelli, Carlo, Stefanini, Giulio G., Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Aucella, Filippo, Barbieri, Greta, Barchitta, Martina, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Castiglione, Giacomo, Cianfrone, Stefania, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Cozzi, Ottavia, Crisetti, Annalisa, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fusco, Francesco Maria, Gentile, Ivan, Graziani, Emauele, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Lio, Veronica, Lucia, Mothanje Barbara, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Manuele, Rosa, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Mussini, Cristina, Musso, Maria, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Pivato, Carlo A., Poletti, Venerino, Ravaglia, Claudia, Rossato, Marco, Rossi, Marianna, Sabena, Anna, Salinaro, Francesco, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scoppettuolo, Giancarlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Trecarichi, Enrico Maria, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A., Costanzo, S., Antinori, A., Berselli, N., Bl, I, L., Bonaccio, M., Cauda, R., Gialluisi, A., Guaraldi, G., Menicanti, L., Mennuni, M., Mussinelli, R., My, I., Parruti, G., Patti, G., Perlini, S., Santilli, F., Signorelli, C., Stefanini, G. G., Vergori, A., Abete, P., Ageno, W., Agostoni, P., Aiello, L., Al Moghazi, S., Arboretti, R., Aucella, F., Barbieri, G., Barchitta, M., Bartoloni, A., Bonfanti, P., Cacciatore, F., Caiano, L., Carrozzi, L., Cascio, A., Castiglione, G., Cianfrone, S., Ciccullo, A., Cingolani, A., Cipollone, F., Colomba, C., Colombo, C., Cozzi, O., Crisetti, A., Crosta, F., Danzi, G. B., D'Ardes, D., de Gaetano Donati, K., Di Gennaro, F., Di Tano, G., D'Offizi, G., Fusco, F. M., Gentile, I., Graziani, E., Guarnieri, G., Larizza, G., Leone, A., Lio, V., Lucia, M. B., Maccagni, G., Madaro, F., Maitan, S., Mancarella, S., Manuele, R., Mapelli, M., Maragna, R., Marcucci, R., Maresca, G., Marongiu, S., Marotta, C., Marra, L., Mastroianni, F., Mazzitelli, M., Mengozzi, A., Menichetti, F., Meschiari, M., Milic, J., Minutolo, F., Molena, B., Mussini, C., Musso, M., Odone, A., Olivieri, M., Palimodde, A., Pasi, E., Pesavento, R., Petri, F., Pinchera, B., Pivato, C. A., Poletti, V., Ravaglia, C., Rossato, M., Rossi, M., Sabena, A., Salinaro, F., Sangiovanni, V., Sanrocco, C., Scoppettuolo, G., Scorzolini, L., Sgariglia, R., Simeone, P. G., Trecarichi, E. M., Vettor, R., Vianello, A., Vinceti, M., Virano, A., Vocciante, L., De Caterina, R., Iacoviello, L., Blandi, L., Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Gialluisi, A, Guaraldi, G, Menicanti, L, Mennuni, M, Mussinelli, R, My, I, Parruti, G, Patti, G, Perlini, S, Santilli, F, Signorelli, C, Stefanini, G, Vergori, A, Abete, P, Ageno, W, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Aucella, F, Barbieri, G, Barchitta, M, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Castiglione, G, Cianfrone, S, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Cozzi, O, Crisetti, A, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fusco, F, Gentile, I, Graziani, E, Guarnieri, G, Larizza, G, Leone, A, Lio, V, Lucia, M, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Manuele, R, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Mussini, C, Musso, M, Odone, A, Olivieri, M, Palimodde, A, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Pivato, C, Poletti, V, Ravaglia, C, Rossato, M, Rossi, M, Sabena, A, Salinaro, F, Sangiovanni, V, Sanrocco, C, Scoppettuolo, G, Scorzolini, L, Sgariglia, R, Simeone, P, Trecarichi, E, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, Iacoviello, L, and De Caterina, R
Subjects: 0301 basic medicine, Male, Physiology, Middle Aged, Renin-Angiotensin System, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, ACE-I, ARB, COVID-19, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, mortality, sartans, Severity of Illness Index, Renin-Angiotensin System, 0302 clinical medicine, Risk Factors, 80 and over, Medicine, Hospital Mortality, Sartan, Aged, 80 and over, Incidence (epidemiology), Incidence, Hazard ratio, Angiotensin Receptor Antagonist, Middle Aged, Hospitalization, Antihypertensive Agent, Italy, Meta-analysis, Hypertension, Sartans, Molecular Medicine, Female, Risk assessment, Human, medicine.medical_specialty, Angiotensin converting enzyme inhibitors, Angiotensin receptor blockers, Mortality, Coronavirus disease 2019 (COVID-19), Risk Assessment, Article, COVID−19, 03 medical and health sciences, Angiotensin Receptor Antagonists, Meta-Analysis as Topic, Internal medicine, Severity of illness, Humans, Angiotensin receptor blocker, Antihypertensive Agents, Aged, Pharmacology, business.industry, Risk Factor, Angiotensin-Converting Enzyme Inhibitor, Confidence interval, 030104 developmental biology, COVID-19, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, mortality, sartans, Observational study, Angiotensin converting enzyme inhibitor, business
Abstract: Objective The hypothesis that been set forward that use of Renin Angiotensin Aldosterone System (RAAS) inhibitors is associated with COVID−19 severity. We set-up a multicenter Italian collaboration (CORIST Project, ClinicalTrials.gov ID: NCT04318418 ) to retrospectively investigate the relationship between RAAS inhibitors and COVID−19 in-hospital mortality. We also carried out an updated meta-analysis on the relevant studies. Methods We analyzed 4069 unselected patients with laboratory-confirmed SARS-CoV-2 infection and hospitalized in 34 clinical centers in Italy from February 19, 2020 to May 23, 2020. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received angiotensin-converting–enzyme inhibitors (ACE I) or angiotensin-receptor blockers (ARB) with patients who did not. Articles for the meta-analysis were retrieved until July 13th, 2020 by searching in web-based libraries, and data were combined using the general variance-based method. Results Out of 4069 COVID−19 patients, 13.5% and 13.3% received ACE-I or ARB, respectively. Use of neither ACE-I nor ARB was associated with mortality (multivariable hazard ratio (HR) adjusted also for COVID−19 treatments: 0.96, 95% confidence interval 0.77–1.20 and HR = 0.89, 0.67–1.19 for ACE-I and ARB, respectively). Findings were similar restricting the analysis to hypertensive (N = 2057) patients (HR = 1.00, 0.78–1.26 and HR = 0.88, 0.65–1.20) or when ACE-I or ARB were considered as a single group. Results from the meta-analysis (19 studies, 29,057 COVID−19 adult patients, 9700 with hypertension) confirmed the absence of association. Conclusions In this observational study and meta-analysis of the literature, ACE-I or ARB use was not associated with severity or in-hospital mortality in COVID−19 patients.
Published: 2020

23. Cytometric analysis of patients with COVID-19: what is changed in the second wave?

Author: Roberto Parrella, Maddalena Raia, Mauro Mormile, Giulia Scalia, Monica Gelzo, Giuseppe Castaldo, Biagio Pinchera, Gabriella Fabbrocini, Sara Cacciapuoti, Agnese Giaccone, Riccardo Scotto, Annunziata De Rosa, Ivan Gentile, Scalia, G., Raia, M., Gelzo, M., Cacciapuoti, S., De Rosa, A., Pinchera, B., Scotto, R., Giaccone, A., Mormile, M., Fabbrocini, G., Gentile, I., Parrella, R., and Castaldo, G.
Subjects: medicine.drug_class, Lymphocyte, Monoclonal antibody, General Biochemistry, Genetics and Molecular Biology, Flow cytometry, Targeted therapy, Immune system, medicine, Humans, Lymphocyte Count, Lymphocytes, Interleukin 6, Pandemics, medicine.diagnostic_test, biology, Pandemic, business.industry, SARS-CoV-2, Interleukin-6, Interleukin, COVID-19, General Medicine, T lymphocyte, medicine.disease, Killer Cells, Natural, medicine.anatomical_structure, Immunology, biology.protein, Medicine, Cytokine storm, business, Cytometry, Human
Abstract: Background Coronavirus disease 2019 (COVID-19) pandemic had a 1st wave in Europe from March to May 2020 and a 2nd wave since September 2020. We previously studied 35 hospitalized COVID-19 patients of the 1st wave demonstrating a cytokine storm and the exhaustion of most lymphocyte subpopulations. Herein, we describe the results obtained from COVID-19 patients of the 2nd wave. Methods We analyzed interleukin (IL)-6 by human-specific enzyme-linked immunosorbent assay and a large set of lymphocyte subpopulations by flow cytometry in 274 COVID-19 patients hospitalized from September 2020 to May 2021. Results Patients of 2nd wave compared with those of 1st wave showed lower serum IL-6 levels and a higher number of B and most T lymphocyte subpopulations in advanced stages, in relation with the age and the gender. On the other hand, we observed in 2nd wave patients: (i) a reduction of most lymphocyte subpopulations at mild and moderate stages; (ii) a reduction of natural killer cells and T regulatory cells together with a higher number of activated T helper (TH) 17 lymphocytes in all stages, which were mainly related to steroid and azithromycin therapies before hospitalization. Conclusions COVID-19 had a less severe impact in patients of the 2nd wave in advanced stages, while the impact appeared more severe in patients of mild and moderate stages, as compared with 1st wave patients. This finding suggests that in COVID-19 patients with milder expression at diagnosis, steroid and azithromycin therapies appear to worsen the immune response against the virus. Furthermore, the cytometric profile may help to drive targeted therapies by monoclonal antibodies to modulate specific IL/lymphocyte inhibition or activation in COVID-19 patients.
Published: 2021

24. Matrix metalloproteinases (MMP) 3 and 9 as biomarkers of severity in COVID-19 patients

Author: Monica Gelzo, Sara Cacciapuoti, Biagio Pinchera, Annunziata De Rosa, Gustavo Cernera, Filippo Scialò, Marika Comegna, Mauro Mormile, Gabriella Fabbrocini, Roberto Parrella, Gaetano Corso, Ivan Gentile, Giuseppe Castaldo, Gelzo, M., Cacciapuoti, S., Pinchera, B., De Rosa, A., Cernera, G., Scialo, F., Comegna, M., Mormile, M., Fabbrocini, G., Parrella, R., Corso, G., Gentile, I., and Castaldo, G.
Subjects: Adult, Male, Multidisciplinary, SARS-CoV-2, Science, Immunology, Patient Acuity, COVID-19, Diseases, Biomarker, Middle Aged, Article, body regions, Medical research, Matrix Metalloproteinase 9, Medicine, Humans, Female, Matrix Metalloproteinase 3, Biomarkers, Aged, Human
Abstract: The molecular basis of the wide clinical heterogeneity of Coronavirus disease 2019 (COVID-19) is still unknown. Matrix metalloproteinases (MMPs) may have a role in the lung damage and regeneration that occur in severe patients. We studied serum MMP3 and MMP9 as potential biomarkers of COVID-19 severity, in 108 hospitalized patients with different World Health Organization (WHO) severity stage and in 48 controls. At hospital admission, serum MMP3 was increased in COVID-19 patients with a significant trend along the progression of the WHO stage, while serum levels of MMP9 were significantly increased in COVID-19 patients with no correlation with disease severity. At 1 week from hospitalization, MMP3 was reduced, suggesting an early pathogenic role of the protein in lung inflammation, while MMP9 levels were further increased, indicating a late role of the protein in the inflammatory process, specifically during the repairing phase. Furthermore, serum MMP9 was positively correlated with serum interleukin-6, myeloperoxidase, and circulating neutrophils and monocytes number. In conclusion, serum MMP3 may help to early predict the severity of COVID-19 and both proteins, MMP3 and MMP9, may contribute to define severe COVID-19 patients that may benefit from a targeted therapy on MMPs.
Published: 2022
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25. mTOR Inhibitor Use Is Associated With a Favorable Outcome of COVID-19 in Patients of Kidney Transplant: Results of a Retrospective Study

Author: Biagio Pinchera, Lorenzo Spirito, Antonio Riccardo Buonomo, Maria Foggia, Rosa Carrano, Fabrizio Salemi, Elisa Schettino, Fortuna Papa, Roberto La Rocca, Felice Crocetto, Luigi Napolitano, Riccardo Villari, Ivan Gentile, Pinchera, B., Spirito, L., Buonomo, A. R., Foggia, M., Carrano, R., Salemi, F., Schettino, E., Papa, F., La Rocca, R., Crocetto, F., Napolitano, L., Villari, R., and Gentile, I.
Subjects: kidney transplant, mTOR inhibitors, SARS-CoV-2, immunosuppressive therapy, COVID-19, General Medicine
Abstract: IntroductionIn solid organ transplant recipients, COVID-19 is associated with a poor prognosis because of immunosuppression. Some studies suggest a potential therapeutic role of mammalian Target of Rapamycin (mTOR) inhibitors in SARS-CoV-2 infection. This study aimed to assess the impact of mTOR employment on the evolution and outcome of SARS-CoV-2 infection in solid organ transplant recipients.MethodsWe enrolled kidney transplant patients attending the Azienda Ospedaliera Universitaria Federico II in Naples and followed up on these patients from March 2020 to June 2021. We evaluated the risk of acquiring the SARS-CoV-2 infection, the clinical presentation of the disease, and its outcome together with the type of immunosuppressive therapy. Finally, we assessed the impact of mTOR inhibitors on relevant clinical metrics of SARS-CoV-2 infection.ResultsWe enrolled 371 patients, of whom 56 (15.1%) contracted SARS-CoV-2 infection during the period of the study. There were no differences observed among the different immunosuppressive therapies concerning the risk of acquiring SARS-CoV-2 infection. In contrast, the type of immunosuppressive therapy had a significant impact on the outcome of the disease. In detail, patients who received mTOR inhibitors, as part of their immunosuppressive therapy, compared to other regimens had a lower chance of developing a moderate or severe form of the disease (OR = 0.8, 95, CI: (0.21–0.92), P = 0.041).ConclusionIn kidney transplant patients, the use of mTOR inhibitors as part of an immunosuppressive regimen is associated with a better prognosis in the case of COVID-19.
Published: 2022

26. Inducible Nitric Oxide Synthase (iNOS): Why a Different Production in COVID-19 Patients of the Two Waves?

Author: Monica Gelzo, Filippo Scialò, Sara Cacciapuoti, Biagio Pinchera, Annunziata De Rosa, Gustavo Cernera, Marika Comegna, Lorella Tripodi, Nicola Schiano Moriello, Mauro Mormile, Gabriella Fabbrocini, Roberto Parrella, Gaetano Corso, Ivan Gentile, Giuseppe Castaldo, Gelzo, M., Scialo, F., Cacciapuoti, S., Pinchera, B., De Rosa, A., Cernera, G., Comegna, M., Tripodi, L., Moriello, N. S., Mormile, M., Fabbrocini, G., Parrella, R., Corso, G., Gentile, I., Castaldo, G., Gelzo, Monica, Scialò, Filippo, Cacciapuoti, Sara, Pinchera, Biagio, De Rosa, Annunziata, Cernera, Gustavo, Comegna, Marika, Tripodi, Lorella, Schiano Moriello, Nicola, Mormile, Mauro, Fabbrocini, Gabriella, Parrella, Roberto, Corso, Gaetano, Gentile, Ivan, and Castaldo, Giuseppe
Subjects: Infectious Diseases, COVID-19, nitric oxide, steroid therapy, SARS-CoV-2, Virology, Steroid therapy, Humans, Nitric Oxide Synthase Type II, Nitric oxide, Human
Abstract: Profound clinical differences between the first and second waves of COVID-19 were observed in Europe. Nitric oxide (NO) may positively impact patients with Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2) infection. It is mainly generated by inducible nitric oxide synthase (iNOS). We studied serum iNOS levels together with serum interleukin (IL)-6 and IL-10 in patients with SARS-CoV-2 infection in the first wave (n = 35) and second wave (n = 153). In the first wave, serum iNOS, IL-6, IL-10 levels increased significantly, in line with the World Health Organization (WHO) score severity, while in the second wave, iNOS did not change with the severity. The patients of the second wave showed lower levels of iNOS, IL-6, and IL-10, as compared to the corresponding subgroup of the first wave, suggesting a less severe outcome of COVID-19 in these patients. However, in the severe patients of the second wave, iNOS levels were significantly lower in patients treated with steroids or azithromycin before the hospitalization, as compared to the untreated patients. This suggests an impairment of the defense mechanism against the virus and NO-based therapies as a potential therapy in patients with low iNOS levels.
Published: 2022

27. Soluble Urokinase Receptor as a Promising Marker for Early Prediction of Outcome in COVID-19 Hospitalized Patients

Author: Ivan Gentile, Filomena Napolitano, Daniela Spalletti Cernia, Carmine Iacovazzo, Maria Vargas, Bianca Covelli, Nunzia Montuori, Loredana Postiglione, Giuseppe Servillo, Margherita Ricciardone, Gaetano Di Spigna, Biagio Pinchera, Napolitano, F., Di Spigna, G., Vargas, M., Iacovazzo, C., Pinchera, B., Cernia, D. S., Ricciardone, M., Covelli, B., Servillo, G., Gentile, I., Postiglione, L., and Montuori, N.
Subjects: ARDS, medicine.medical_specialty, Complement system, Coronavirus disease 2019 (COVID-19), Sepsi, Article, law.invention, Sepsis, sepsis, law, Internal medicine, Pandemic, Health care, medicine, SuPAR, business.industry, Risk stratification in the emergency room, biomarkers, COVID-19, General Medicine, Biomarker, medicine.disease, Intensive care unit, Urokinase receptor, Medicine, business
Abstract: The Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, has rapidly spread to become a global pandemic, putting a strain on health care systems. SARS-CoV-2 infection may be associated with mild symptoms or, in severe cases, lead patients to the intensive care unit (ICU) or death. The critically ill patients suffer from acute respiratory distress syndrome (ARDS), sepsis, thrombotic complications and multiple organ failure. For optimization of hospital resources, several molecular markers and algorithms have been evaluated in order to stratify COVID-19 patients, based on the risk of developing a mild, moderate, or severe disease. Here, we propose the soluble urokinase receptor (suPAR) as a serum biomarker of clinical severity and outcome in patients who are hospitalized with COVID-19. In patients with mild disease course, suPAR levels were increased as compared to healthy controls, but they were dramatically higher in severely ill patients. Since early identification of disease progression may facilitate the individual management of COVID-19 symptomatic patients and the time of admission to the ICU, we suggest paying more clinical attention on patients with high suPAR levels.
Published: 2021

28. Case Report: Discovery a Novel SARS-CoV-2 Variant in a Six-Months Long-Term Swab Positive Female Suffering From Non-Hodgkin Lymphoma

Author: Ettore Capoluongo, Carmela Nardelli, Maria Valeria Esposito, Antonio Riccardo Buonomo, Monica Gelzo, Biagio Pinchera, Emanuela Zappulo, Giulio Viceconte, Giuseppe Portella, Mario Setaro, Ivan Gentile, Giuseppe Castaldo, Capoluongo, E., Nardelli, C., Esposito, M. V., Buonomo, A. R., Gelzo, M., Pinchera, B., Zappulo, E., Viceconte, G., Portella, G., Setaro, M., Gentile, I., and Castaldo, G.
Subjects: 0301 basic medicine, Cancer Research, ORF3a, Case Report, long-term infection, Virus, Frameshift mutation, 03 medical and health sciences, 0302 clinical medicine, Immune system, Immunophenotyping, medicine, Seroconversion, RC254-282, Immunodeficiency, whole genome sequencing, business.industry, SARS-CoV-2, Immunogenicity, non-Hodgkin lymphoma, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Lymphoma, novel variant, 030104 developmental biology, Oncology, Immunology, business, 030217 neurology & neurosurgery
Abstract: BackgroundWe report the case of a woman with non-Hodgkin lymphoma who remained positive on the molecular assay for SARS-CoV-2 for six months: she has never experienced a severe form of COVID-19 although in absence of seroconversion.MethodsThe whole SARS-CoV-2 genome analysis was performed by the CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel (PARAGON GENOMICS, Hayward, USA).ResultsWe found twenty-two mutations in SARS-CoV-2 genome and a novel deleterious ORF3a frameshift c.766_769del corresponding to a unique and novel lineage. The region affected by this frameshift variant is reported as being important in determining SARS-CoV-2 immunogenicity. Patient’s immunophenotype showed the absence of B lymphocytes and significantly reduced T-cell count. Only after the treatment with hyperimmune plasma she finally became negative on the swab.ConclusionsOur findings could be helpful in the management of patients with immunodeficiency, particularly when novel variants, potentially altering the virus immune response, are present.
Published: 2021

29. Dementia as Risk Factor for Severe Coronavirus Disease 2019: A Case-Control Study

Author: Mariantonietta Pisaturo, Federica Calò, Antonio Russo, Clarissa Camaioni, Agnese Giaccone, Biagio Pinchera, Ivan Gentile, Filomena Simeone, Angelo Iodice, Paolo Maggi, Nicola Coppola, Pisaturo, Mariantonietta, Calò, Federica, Russo, Antonio, Camaioni, Clarissa, Giaccone, Agnese, Pinchera, Biagio, Gentile, Ivan, Simeone, Filomena, Iodice, Angelo, Maggi, Paolo, Coppola, Nicola, Pisaturo, M., Calo, F., Russo, A., Camaioni, C., Giaccone, A., Pinchera, B., Gentile, I., Simeone, F., Iodice, A., Maggi, P., and Coppola, N.
Subjects: medicine.medical_specialty, Aging, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Cognitive Neuroscience, severity, Neurosciences. Biological psychiatry. Neuropsychiatry, Disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, death, Medicine, Dementia, 030212 general & internal medicine, Risk factor, Original Research, business.industry, SARS-CoV-2, Case-control study, COVID-19, medicine.disease, Delirium, Observational study, medicine.symptom, business, 030217 neurology & neurosurgery, RC321-571, Neuroscience, dementia
Abstract: BackgroundThe aim of the present study was to investigate the outcome of patients with SARS-CoV-2 infection and dementia.Patients and MethodsIn a multicenter, observational, 1:2 matched case-control study all 23 patients with a history of dementia, hospitalized with a diagnosis of SARS-CoV-2 infection from February 28th 2020 to January 31st 2021 were enrolled. For each Case, 2 patients without dementia observed in the same period study, pair matched for gender, age (±5 years), PaO2/FiO2 (P/F) ratio at admission (200), number of comorbidities (±1; excluding dementia) were chosen (Control group).ResultsThe majority of patients were males (60.9% of Cases and Controls) and very elderly [median age 82 years (IQR: 75.5–85) in the Cases and 80 (IQR: 75.5–83.75) in the Controls]. The prevalence of co-pathologies was very high: all the Cases and 43 (93.5%) Controls showed a Charlson comorbidity index of at least 2. During hospitalization the patients in the Case group less frequently had a moderate disease of COVID-19 (35 vs. 67.4%, p = 0.02), more frequently a severe disease (48 vs. 22%, p = 0.03) and more frequently died (48 vs. 22%, p = 0.03). Moreover, during coronavirus disease 2019 (COVID-19), 14 (60.8%) patients in the Case group and 1 (2.1%; p < 0.000) in the Control group showed signs and symptoms of delirium.ConclusionPatients with dementia are vulnerable and have an increased risk of a severe disease and death when infected with COVID-19.
Published: 2021
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30. Prognostic Role of Neutrophil to Lymphocyte Ratio in COVID-19 Patients: Still Valid in Patients That Had Started Therapy?

Author: Monica Gelzo, Sara Cacciapuoti, Biagio Pinchera, Annunziata De Rosa, Gustavo Cernera, Filippo Scialò, Mauro Mormile, Gabriella Fabbrocini, Roberto Parrella, Ivan Gentile, Giuseppe Castaldo, Gelzo, M., Cacciapuoti, S., Pinchera, B., De Rosa, A., Cernera, G., Scialo, F., Mormile, M., Fabbrocini, G., Parrella, R., Gentile, I., and Castaldo, G.
Subjects: medicine.medical_specialty, Prognosi, Neutrophils, Lymphocyte, corticosteroid therapy, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Internal medicine, medicine, Humans, 030212 general & internal medicine, Lymphocytes, Lymphocyte Count, Neutrophil to lymphocyte ratio, Stage (cooking), Interleukin 6, neutrophil to lymphocyte ratio, Retrospective Studies, Predictive marker, biology, business.industry, SARS-CoV-2, interleukin-6, Public Health, Environmental and Occupational Health, Interleukin, COVID-19, Retrospective cohort study, Brief Research Report, Prognosis, myeloperoxidase, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Myeloperoxidase, biology.protein, Public Health, Public aspects of medicine, RA1-1270, business, Human
Abstract: COVID-19 may appear with a widely heterogeneous clinical expression. Thus, predictive markers of the outcome/progression are of paramount relevance. The neutrophil/lymphocyte ratio (NLR) has been suggested as a good predictive marker of disease severity and mortality. Accordingly, we found that NLR significantly increased in parallel with the WHO severity stage in COVID-19 patients during the Ist wave (March-May 2020; n = 49), due to the significant reduction of lymphocyte and the significant increase of neutrophil in severe COVID-19 patients. While, we did not observe significant differences of NLR between the WHO severity stage among COVID-19 patients of the IInd wave (September 2020-April 2021; n = 242). In these patients, the number of lymphocytes and neutrophils did not change significantly between patients of different severity subgroups. This difference likely depends on the steroids therapy that the patients of the IInd wave performed before hospitalization while most patients of the Ist wave were hospitalized soon after diagnosis. This is also confirmed by serum interleukin (IL)-6 and myeloperoxidase (MPO) that gradually increased with the disease stage in patients of the Ist wave, while such biomarkers (whose production is inhibited by steroids) did not show differences among patients of the IInd wave in different stages. Thus, the NLR could be tested at diagnosis in naïve patients before starting therapies.
Published: 2021
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31. More Severe COVID-19 in Patients With Active Cancer: Results of a Multicenter Cohort Study

Author: Paolo Maggi, Caterina Sagnelli, Angelo Salomone Megna, Alfonso Masullo, Mario Catalano, Elio Manzillo, Giovanni Porta, Mariantonietta Pisaturo, Vincenzo Sangiovanni, Vincenzo Esposito, Enrico Allegorico, Raffaella Pisapia, Carolina Rescigno, Vincenzo Messina, Michele Gambardella, Caterina Monari, Clarissa Camaioni, Giuseppe Signoriello, Fabio Giuliano Numis, Giosuele Calabria, Angela Salzillo, Ivan Gentile, Grazia Russo, Nicola Coppola, Biagio Pinchera, Monari, C., Sagnelli, C., Maggi, P., Sangiovanni, V., Numis, F. G., Gentile, I., Masullo, A., Rescigno, C., Calabria, G., Megna, A. S., Gambardella, M., Manzillo, E., Russo, G., Esposito, V., Camaioni, C., Messina, V., Pisaturo, M., Allegorico, E., Pinchera, B., Pisapia, R., Catalano, M., Salzillo, A., Porta, G., Signoriello, G., Coppola, N., Monari, Caterina, Sagnelli, Caterina, Maggi, Paolo, Sangiovanni, Vincenzo, Numis, Fabio Giuliano, Gentile, Ivan, Masullo, Alfonso, Rescigno, Carolina, Calabria, Giosuele, Megna, Angelo Salomone, Gambardella, Michele, Manzillo, Elio, Russo, Grazia, Esposito, Vincenzo, Camaioni, Clarissa, Messina, Vincenzo, Pisaturo, Mariantonietta, Allegorico, Enrico, Pinchera, Biagio, Pisapia, Raffaella, Catalano, Mario, Salzillo, Angela, Porta, Giovanni, Signoriello, Giuseppe, and Coppola, Nicola
Subjects: 0301 basic medicine, Cancer Research, medicine.medical_specialty, Multivariate analysis, medicine.medical_treatment, oncologic patient, severity disease, active cancer, Malignancy, 03 medical and health sciences, 0302 clinical medicine, Intensive care, Internal medicine, medicine, Stage (cooking), RC254-282, Original Research, Mechanical ventilation, SARS-CoV-2, business.industry, COVID-19, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Cancer, Retrospective cohort study, medicine.disease, oncologic patients, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, business, Cohort study
Abstract: BackgroundThe aim of the study was to compare coronavirus disease 2019 (COVID-19) severity presentation between oncologic and non-oncologic patients and to evaluate the impact of cancer type and stage on COVID-19 course.MethodsWe performed a multicentre, retrospective study involving 13 COVID-19 Units in Campania region from February to May 2020. We defined as severe COVID-19 presentation the cases that required mechanical ventilation and/or admission to Intensive Care Units (ICU) and/or in case of death.ResultsWe enrolled 371 COVID-19 patients, of whom 34 (9.2%) had a history or a diagnosis of cancer (24 solid, 6 onco-hematological). Oncologic patients were older (pConclusionsSince the higher risk of severe evolution of COVID-19, cancer patients, especially those with an active malignancy, should be candidates for early evaluation of symptoms and early treatment for COVID-19.
Published: 2021
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32. Lymphocyte Population Changes at Two Time Points during the Acute Period of COVID-19 Infection

Author: Giulia Scalia, Maddalena Raia, Monica Gelzo, Sara Cacciapuoti, Annunziata De Rosa, Biagio Pinchera, Riccardo Scotto, Lorella Tripodi, Mauro Mormile, Gabriella Fabbrocini, Ivan Gentile, Roberto Parrella, Giuseppe Castaldo, Filippo Scialò, Scalia, Giulia, Raia, Maddalena, Gelzo, Monica, Cacciapuoti, Sara, Rosa, Annunziata De, Pinchera, Biagio, Scotto, Riccardo, Tripodi, Lorella, Mormile, Mauro, Fabbrocini, Gabriella, Gentile, Ivan, Parrella, Roberto, Castaldo, Giuseppe, Scialò, Filippo, Scalia, G., Raia, M., Gelzo, M., Cacciapuoti, S., Rosa, A. D., Pinchera, B., Scotto, R., Tripodi, L., Mormile, M., Fabbrocini, G., Gentile, I., Parrella, R., Castaldo, G., and Scialo, F.
Subjects: COVID-19, lymphocyte subpopulations, serum interleukins, steroid therapy, serum interleukin, lymphocyte subpopulation, General Medicine
Abstract: We previously observed an increase of serum interleukins (IL) and a reduction of most lymphocyte subpopulations in hospitalized COVID-19 patients. Herein, we aimed to evaluate the changes in serum IL-6, IL-10, and IL-17A levels and cytometric lymphocyte profiles in 144 COVID-19 patients at admission and after one week, also in relation to steroid treatment before hospitalization. After one week of hospitalization, we found that: (i) total lymphocytes were increased in all patients; (ii) neutrophils and IL-6 were reduced in mild/moderate patients; (iii) B lymphocytes were increased in severe patients; (iv) T lymphocyte populations increased in mild/moderate patients. In the eight patients that died during hospitalization, total leukocytes increased while T, T helper, T cytotoxic, T regulatory, and NK lymphocytes showed a reducing trend in five of the eight patients. Even if seven days are too few to evaluate the adaptive immunity of patients, we found that the steroid therapy was associated with a reduced COVID-19 inflammation and cytokine activation only in patients with severe disease, while in patients with less severe disease, the steroid therapy seems to have immunosuppressive effects on lymphocyte populations, and this could hamper the antiviral response. A better knowledge of cytokine and lymphocyte alterations in each COVID-19 patient could be useful to plan better treatment with steroids or cytokine targeting.
Published: 2022
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33. Serum KL-6 Could Represent a Reliable Indicator of Unfavourable Outcome in Patients with COVID-19 Pneumonia

Author: Lidia Atripaldi, Nicola Schiano Moriello, Marialuisa Bocchino, Alessia Sardanelli, Biagio Pinchera, Agnese Giaccone, Davide Sequino, Emanuela Zappulo, Alessandro Sanduzzi, Anna Agnese Stanziola, Riccardo Scotto, Francesco Perna, Ivan Gentile, Scotto, R., Pinchera, B., Perna, F., Atripaldi, L., Giaccone, A., Sequino, D., Zappulo, E., Sardanelli, A., Moriello, N. S., Stanziola, A., Bocchino, M., Gentile, I., and Sanduzzi Zamparelli, A.
Subjects: Male, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Health, Toxicology and Mutagenesis, lcsh:Medicine, Gastroenterology, Article, 03 medical and health sciences, 0302 clinical medicine, Antigen, Internal medicine, medicine, Humans, pneumonia, In patient, 030212 general & internal medicine, Lung, medicine.diagnostic_test, biology, business.industry, SARS-CoV-2, lcsh:R, Mucin-1, KL-6, Public Health, Environmental and Occupational Health, COVID-19, Biomarker, Middle Aged, medicine.disease, mortality, Pneumonia, medicine.anatomical_structure, 030228 respiratory system, Respiratory failure, Immunoassay, biology.protein, Female, Antibody, business, Biomarkers, Human
Abstract: KL-6 is a sialoglycoprotein antigen which proved elevated in the serum of patients with different interstitial lung diseases, especially in those with a poorer outcome. Given that interstitial pneumonia is the most common presentation of SARS-CoV2 infection, we evaluated the prognostic role of KL-6 in patients with COVID-19 pneumonia. Patients with COVID-19 pneumonia were prospectively enrolled. Blood samples were collected at the time of enrolment (TOE) and on day 7 (T1). Serum KL-6 concentrations were measured by chemiluminescence enzyme immunoassay using a KL-6 antibody kit (LUMIPULSE G1200, Fujirebio) and the cut-off value was set at &gt, 1000 U/mL. Fifteen out of 34 enrolled patients (44.1%) died. Patients with unfavourable outcome showed significantly lower P/F ratio and higher IL-6 values and plasmatic concentrations of KL-6 at TOE compared with those who survived (median KL-6: 1188 U/mL vs. 260 U/mL, p &lt, 0.001). KL-6 &gt, 1000 U/mL resulted independently associated with death (aOR: 11.29, p &lt, 0.05) with a positive predictive value of 83.3%. Our results suggest that KL-6 is a reliable indicator of pulmonary function and unfavourable outcome in patients with COVID-19 pneumonia. A KL-6 value &gt, 1000 U/mL resulted independently associated with death and showed good accuracy in predicting a poorer outcome. KL-6 may thus represent a quick, inexpensive, and sensitive parameter to stratify the risk of severe respiratory failure and death.
Published: 2021

34. A transient increase in the serum ancas in patients with sars-cov-2 infection: A signal of subclinical vasculitis or an epiphenomenon with no clinical manifestations? a pilot study

Author: Filippo Scialò, Biagio Pinchera, Monica Gelzo, Sara Cacciapuoti, Marika Comegna, Mauro Mormile, Roberto Parrella, Giuseppe Castaldo, Ivan Gentile, Gustavo Cernera, Antonella Gallicchio, Gabriella Fabbrocini, Annunziata De Rosa, Gaetano Corso, Gelzo, M., Cacciapuoti, S., Pinchera, B., De Rosa, A., Cernera, G., Scialo, F., Comegna, M., Mormile, M., Gallicchio, A., Fabbrocini, G., Parrella, R., Corso, G., Gentile, I., and Castaldo, G.
Subjects: Adult, Male, medicine.medical_specialty, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), viruses, Endothelial damage, MPO, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculiti, Epiphenomenon, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Pilot Projects, medicine.disease_cause, Gastroenterology, Asymptomatic, Microbiology, Autoimmunity, Antibodies, Antineutrophil Cytoplasmic, Antigen, Virology, Internal medicine, medicine, Humans, In patient, Pilot Project, cardiovascular diseases, skin and connective tissue diseases, Subclinical infection, Immunoassay, business.industry, ANCA, SARS-CoV-2, Brief Report, COVID-19, Middle Aged, medicine.disease, PR3, QR1-502, respiratory tract diseases, Infectious Diseases, Female, Disease Susceptibility, medicine.symptom, Symptom Assessment, business, Vasculitis, Human
Abstract: A relationship is emerging between SARS-CoV-2 infections and ANCA-associated vasculitis (AAV) because: (i) the pulmonary involvement of COVID-19 may mimic that observed in patients with AAV; (ii) the two diseases may occur together; (iii) COVID-19 may trigger AAV. However, few cases of AAV have been identified so far in COVID-19 patients. To define the frequency of ANCA autoimmunity in patients with SARS-CoV-2 infection, we analyzed the serum ANCAs and the serum PR3 and MPO antigens by immunoassays in 124 adult patients with a diagnosis of SARS-CoV-2 infection (16 were asymptomatic and 108 were hospitalized) and 48 control subjects. The serum ANCAs were significantly higher in the hospitalized patients compared with either the controls or the asymptomatic patients and increased with the progression of the COVID-19 severity. After one week of hospitalization, the values were significantly lower. In contrast, no differences emerged among the controls, asymptomatic and hospitalized patients for the PR3 and MPO serum levels. None of the patients had clinical signs of AAV with the exception of a severe pulmonary involvement. Further studies are necessary to define whether the increase in the serum ANCAs might mask subclinical vasculitis in a percentage of patients with SARS-CoV-2 infection or it is an epiphenomenon of SARS-CoV-2 infection with no clinical manifestations.
Published: 2021

35. Changing epidemiology of patients treated with direct acting antivirals for HCV and persistently high SVR12 in an endemic area for HCV infection in Italy: real-life ‘LIver Network Activity’ (LINA) cohort update results

Author: Salvatore Martini, Simona Mercinelli, Nicola Coppola, Biagio Pinchera, Vincenzo Messina, Carmine Coppola, G. Stornaiuolo, Maria Stanzione, Mariagiovanna Nerilli, Riccardo Scotto, Antonio Riccardo Buonomo, Ivan Gentile, Laura Staiano, Stefania De Pascalis, Letizia Cattaneo, Scotto, R., Buonomo, A. R., De Pascalis, S., Nerilli, M., Pinchera, B., Staiano, L., Mercinelli, S., Cattaneo, L., Stanzione, M., Stornaiuolo, G., Martini, S., Messina, V., Coppola, C., Coppola, N., Gentile, I., Scotto, Riccardo, Buonomo, Antonio Riccardo, De Pascalis, Stefania, Nerilli, Mariagiovanna, Pinchera, Biagio, Staiano, Laura, Mercinelli, Simona, Cattaneo, Letizia, Stanzione, Maria, Stornaiuolo, Gianfranca, Martini, Salvatore, Messina, Vincenzo, Coppola, Carmine, Coppola, Nicola, and Gentile, Ivan
Subjects: Research design, Cyclopropanes, Liver Cirrhosis, Male, Cirrhosis, Aminoisobutyric Acids, Pyrrolidines, Sustained Virologic Response, Hepacivirus, DIRECT ACTING ANTIVIRALS, Liver disease, 0302 clinical medicine, Epidemiology, Prospective Studies, Prospective cohort study, Sulfonamides, Gastroenterology, Imidazoles, Endemic area, Middle Aged, Italy, 030220 oncology & carcinogenesis, Cohort, HCV, 030211 gastroenterology & hepatology, Female, epidemiology, Adult, medicine.medical_specialty, Genotype, Proline, Lactams, Macrocyclic, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, 03 medical and health sciences, Age Distribution, Leucine, Internal medicine, Quinoxalines, medicine, Humans, real-life, Aged, Benzofurans, Retrospective Studies, DAA, Hepatology, business.industry, Hepatitis C, Chronic, medicine.disease, Amides, SVR12, Benzimidazoles, Carbamates, business
Abstract: Background: Second generation direct acting antivirals (DAAs) drastically changed the landscape of chronic HCV (CHCV). Aim of this paper was to assess the effectiveness of DAAs, also looking at the demographic characteristics of subjects enrolled. Research design and methods: Ambispective multi-center real-life study conducted among patients with CHCV treated with DAAs in Campania Region (Southern Italy). Patient were enrolled in two cohorts according to time of enrolment. Results: 1,479 patients were enrolled. Patients aged ≥60 years were 74.7% in the historic cohort (953 patients) and 70.2% in the prospective cohort (526 patients. Patients aged ≥ 60 years showed a higher prevalence of genotype 1b (p
Published: 2021

36. Further Findings Concerning Endothelial Damage in COVID-19 Patients

Author: Roberto Parrella, Annunziata De Rosa, Gaetano Corso, Marika Comegna, Giuseppe Castaldo, Sara Cacciapuoti, Gabriella Fabbrocini, Ivan Gentile, Mauro Mormile, Gustavo Cernera, Filippo Scialò, Biagio Pinchera, Monica Gelzo, Gelzo, M., Cacciapuoti, S., Pinchera, B., De Rosa, A., Cernera, G., Scialo, F., Comegna, M., Mormile, M., Fabbrocini, G., Parrella, R., Corso, G., Gentile, I., and Castaldo, G.
Subjects: Adult, Male, medicine.medical_specialty, P-selectin, monocyte chemotactic protein, Monocyte, Microbiology, Biochemistry, CCL8, Asymptomatic, Gastroenterology, Monocytes, Article, Pathogenesis, Internal medicine, E-selectin, medicine, Chemokine CCL8, Humans, Platelet, Stage (cooking), Molecular Biology, Aged, biology, SARS-CoV-2, business.industry, COVID-19, Middle Aged, QR1-502, medicine.anatomical_structure, biology.protein, Female, Endothelium, Vascular, medicine.symptom, MCP-2, business, Human
Abstract: Systemic vascular damage with micro/macro-thrombosis is a typical feature of severe COVID-19. However, the pathogenesis of this damage and its predictive biomarkers remain poorly defined. For this reason, in this study, serum monocyte chemotactic protein (MCP)-2 and P- and E-selectin levels were analyzed in 204 patients with COVID-19. Serum MCP-2 and P-selectin were significantly higher in hospitalized patients compared with asymptomatic patients. Furthermore, MCP-2 increased with the WHO stage in hospitalized patients. After 1 week of hospitalization, MCP-2 levels were significantly reduced, while P-selectin increased in patients in WHO stage 3 and decreased in patients in WHO stages 5–7. Serum E-selectin was not significantly different between asymptomatic and hospitalized patients. The lower MCP-2 levels after 1 week suggest that endothelial damage triggered by monocytes occurs early in COVID-19 disease progression. MCP-2 may also predict COVID-19 severity. The increase in P-selectin levels, which further increased in mild patients and reduced in severe patients after 1 week of hospitalization, suggests that the inactive form of the protein produced by the cleavage of the active protein from the platelet membrane is present. This may be used to identify a subset of patients that would benefit from targeted therapies. The unchanged levels of E-selectin in these patients suggest that endothelial damage is less relevant.
Published: 2021
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37. Novel strategies for the management of bacterial and fungal infections in patients with liver cirrhosis: focus on new antimicrobials

Author: Nicola Schiano Moriello, Antonio Riccardo Buonomo, Salatore Nappa, Biagio Pinchera, Ivan Gentile, Emanuela Zappulo, Riccardo Scotto, Alberto Enrico Maraolo, Maraolo, A. E., Scotto, R., Zappulo, E., Pinchera, B., Schiano Moriello, N., Nappa, S., Buonomo, A. R., and Gentile, I.
Subjects: 0301 basic medicine, Microbiology (medical), Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Antifungal Agents, 030106 microbiology, Population, multidrug-resistant pathogen, Microbiology, Liver cirrhosi, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Immune system, Virology, Internal medicine, Drug Resistance, Multiple, Bacterial, Drug Resistance, Multiple, Fungal, medicine, novel beta-lactams, Humans, 030212 general & internal medicine, education, education.field_of_study, business.industry, fungal infection, bacterial infection, Bacterial Infections, Antimicrobial, medicine.disease, Review article, Anti-Bacterial Agents, Infectious Diseases, Tolerability, Mycoses, Etiology, business
Abstract: Introduction: Liver cirrhosis is a frequent condition caused by different etiologies. Bacterial and fungal infections are common complications, representing an independent prognostic stage in patients with cirrhosis, dramatically worsening their clinical outcomes. Areas covered: The present review article addresses manifold points and to this purpose an inductive literature search of MEDLINE database through PubMed was performed. First, it provides an overview on the mechanisms underlying immune disfunctions in patients with cirrhosis, who are prone to develop infections being at higher risk than the general population. Second, commonest types of bacterial and fungal infections in patients with advanced liver disease are described, focusing on their deleterious impact as decompensating events. Third, the rise of multidrug-resistant (MDR) bacteria and fungi as causative agents of infection in cirrhotic subjects is illustrated. Eventually, the most promising novel therapeutic options against MDR pathogens and fungi are reviewed. Expert opinion: The management of bacterial and fungal infections in patients with cirrhosis is difficult, due to the frequent co-existence of renal impairment, low platelet count and other conditions that limit the antimicrobial choice. New antibacterial and antifungal compounds may overcome this issue by providing a better tolerability profile, along with equal or superior efficacy compared with older drugs.
Published: 2020

38. Efficacy and safety of a fixed dose combination tablet of asunaprevir + beclabuvir + daclatasvir for the treatment of Hepatitis C

Author: Alberto Enrico Maraolo, Riccardo Scotto, Biagio Pinchera, Antonio Riccardo Buonomo, Emanuela Zappulo, Ivan Gentile, Zappulo, E., Scotto, R., Buonomo, A. R., Maraolo, A. E., Pinchera, B., and Gentile, I.
Subjects: Liver Cirrhosis, medicine.medical_specialty, Indoles, Pyrrolidines, Cirrhosis, Daclatasvir, Genotype, Sustained Virologic Response, Hepatitis C virus, Fixed-dose combination, interferon-free combination, Hepacivirus, medicine.disease_cause, Antiviral Agents, Gastroenterology, chemistry.chemical_compound, Internal medicine, medicine, Humans, Pharmacology (medical), Beclabuvir, DAA, Pharmacology, Sulfonamides, business.industry, Imidazoles, BMS-79125, DCV-TRIO, food and beverages, Valine, General Medicine, Hepatitis C, Benzazepines, Hepatitis C, Chronic, Isoquinolines, medicine.disease, Drug Combinations, Chronic infection, Treatment Outcome, chemistry, Ximency®, HCV, Asunaprevir, Carbamates, business, Tablets, medicine.drug
Abstract: Introduction: Hepatitis C virus (HCV) is estimated to infect approximately 70 million people worldwide. If left untreated, chronic infection can progress to cirrhosis, liver failure or hepatocellular carcinoma. The advent of new direct-acting antivirals (DAA) has revolutionized patients’ chances of treatment and viral elimination. Currently, several DAA options are available on the market. Areas covered: This review focuses on the pharmacokinetics, efficacy, tolerability and safety profile of DCV-TRIO, a twice-daily fixed-dose combination of daclatasvir, asunaprevir and beclabuvir approved in Japan for the treatment of genotype 1 HCV infection. Expert opinion: The DCV-TRIO combination achieved good response rates in genotype 1 patients (SVR12 ≥ 95% in naïve subtype 1b), independently from IL28B genotype, cirrhotic status and prior interferon exposure. On the other hand, unsatisfying response rates were reported in DAA-experienced patients and the risk of RAS selection should not be underestimated. Moreover, DCV-TRIO lacks differentiation from its earlier-launched DAA rivals, presents an inconvenient twice-daily dosing schedule and is not recommended in patients with advanced liver and kidney disease. All these drawbacks considerably limit its effective commercial potential. However, it can be a therapeutic option against HCV in tailored approaches according to the needs of different markets across the world. Abbreviations AE: adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; ASV: asunaprevir; AUC: area under the curve; BCRP: Breast Cancer Resistance Protein; BCV: boceprevir; BID: bis in die; CI: confidence intervals; CLcr: creatinine clearance; DAA: direct acting antivirals; DCV: daclatasvir; EC50: Half maximal effective concentration; GT: genotype; HCV: Hepatitis C virus; IFN: Interferon; NHL: non-Hodgkin lymphoma; OATP: Organic anion transporting polypeptides; OR: odds ratio; P-gp: P-glycoprotein; PK: pharmacokinetics; QD: quo die; RAS: resistance-associated substitutions; SVR: sustained virological response; USD: Unites States dollar.
Published: 2020

39. Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence: Results from an Italian real-life cohort (LINA cohort)

Author: Riccardo Scotto, Grazia Tosone, Salvatore Nappa, Mariarosaria Saturnino, Costanza Maria Rapillo, Giulio Viceconte, Ivan Gentile, Stefania De Pascalis, Carmine Coppola, Salvatore Martini, Federica Portunato, Antonio Riccardo Buonomo, Ferdinando Scarano, Laura Staiano, Mariantonietta Pisaturo, Nicola Coppola, Biagio Pinchera, Buonomo, A. R., Scotto, R., Coppola, C., Pinchera, B., Viceconte, G., Rapillo, C. M., Staiano, L., Saturnino, M., Scarano, F., Portunato, F., Pisaturo, M., De Pascalis, S., Martini, S., Tosone, G., Nappa, S., Coppola, N., and Gentile, I.
Subjects: Male, medicine.medical_specialty, real-world, Carcinoma, Hepatocellular, Hepatitis C virus, medicine.disease_cause, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, direct acting antiviral, Internal medicine, medicine, 030212 general & internal medicine, Prospective cohort study, Survival analysis, Aged, Antiviral Agent, business.industry, Incidence (epidemiology), Incidence, General Medicine, Hepatitis C, hepatocellular carcinoma, Hepatitis C, Chronic, Middle Aged, medicine.disease, Survival Analysis, digestive system diseases, Prospective Studie, Italy, Liver Neoplasm, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Cohort, HCV, Female, Cohort Studie, business, Cohort study, Human
Abstract: The effectiveness of direct-acting antivirals (DAAs) against hepatitis C virus (HCV) infection is ascertained. However, some authors raised the issue of an increased incidence of de novo hepatocellular carcinoma (HCC) in patients treated with DAAs. Aim of the study was to evaluate the rate of HCC occurrence in a real-life cohort of patients who received anti-HCV treatment with DAAs.A prospective multicentre study was conducted. All adult patients with HCV infection who received treatment between March 2015 and December 2017 in 4 hospital of Campania region (South Italy) with at least 6 months of follow-up were enrolled.A total of 323 patients were included in the study. Most patients had HCV genotype 1b (61.8%). The overall SVR12 rate was 95.5%. Median time of observation was 10 months. The incidence rate of HCC was 0.2 per 100 person-months (crude incidence rate 3.4%, 95 confidence interval: 1.5%-5.3%). The median time for HCC occurrence was 11 months. HCC occurrence rate was significantly higher among patients who did not achieve SVR12 compared with patients who did (28.6% vs 2.8%, P
Published: 2020

40. Direct-acting antivirals improve endothelial function in patients with chronic hepatitis: a prospective cohort study

Author: Francesco Borgia, Consalvo Mattia, Ivan Gentile, Riccardo Scotto, Pasquale Ambrosino, Biagio Pinchera, Matteo Nicola Dario Di Minno, Ilenia Calcaterra, Antonio Riccardo Buonomo, Manuel Crispo, Di Minno, M. N. D., Ambrosino, P., Buonomo, A. R., Pinchera, B., Calcaterra, ILENIA LORENZA, Crispo, M., Scotto, R., Borgia, F., Mattia, C., and Gentile, I.
Subjects: Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Direct-acting antiviral agent, Hepatitis C virus, Cardiovascular risk factors, Hepacivirus, 030204 cardiovascular system & hematology, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, Chronic hepatitis C, Risk profile, Gastroenterology, Antiviral Agents, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Chronic hepatitis, Internal medicine, Internal Medicine, medicine, Humans, In patient, 030212 general & internal medicine, Endothelium, Prospective Studies, Prospective cohort study, Aged, Hepatitis, Chronic, business.industry, Endothelial function, chronic hepatitis C, direct-acting antiviral agents, endothelial function, Middle Aged, Protective Factors, medicine.disease, Hepatitis C, Italy, Emergency Medicine, Female, business
Abstract: Hepatitis C virus (HCV) infection is associated with increased cardiovascular risk. We evaluated effects of direct-acting antiviral agents (DAAs) on flow-mediated dilation (FMD), a recognized marker of cardiovascular risk. We evaluated FMD and post-ischemic hyperemia (PIH) in consecutive HCV out-patients before starting DAAs, at the end of treatment (Teot) and 12 weeks thereafter. In 22 HCV subjects (age 64.0 years), baseline FMD was 4.52% ± 1.90 and PIH of 5814.4 (IQR 3786.9–7861.9). At (Teot), all patients showed undetectable levels of HCV-RNA and FMD changed from 4.52% ± 1.90 to 9.39% ± 4.06 (p
Published: 2019

41. Interferon-free regimens improve kidney function in patients with chronic hepatitis C infection

Author: Salvatore Martini, Daniela Caterina Amoruso, Stefania De Pascalis, Antonio Riccardo Buonomo, Federica Portunato, Ivan Gentile, Mariantonietta Pisaturo, Nicola Coppola, Biagio Pinchera, Laura Staiano, Carmine Coppola, Riccardo Scotto, Coppola, N., Portunato, F., Buonomo, A. R., Staiano, L., Scotto, R., Pinchera, B., De Pascalis, S., Amoruso, D. C., Martini, S., Pisaturo, M., Coppola, C., Gentile, I., Coppola, Nicola, Portunato, Federica, Buonomo, Antonio Riccardo, Staiano, Laura, Scotto, Riccardo, Pinchera, Biagio, De Pascalis, Stefania, Amoruso, Daniela Caterina, Martini, Salvatore, Pisaturo, Mariantonietta, Coppola, Carmine, and Gentile, Ivan
Subjects: Male, Nephrology, medicine.medical_specialty, Cirrhosis, Hepatitis C virus, 030232 urology & nephrology, Renal function, 030204 cardiovascular system & hematology, medicine.disease_cause, Antiviral Agents, Gastroenterology, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Diabetes mellitus, medicine, CKD, eGFR, Humans, Aged, DAA, Antiviral Agent, business.industry, Recovery of Function, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Symptom Flare Up, medicine.disease, HCV infection, Regimen, Treatment Outcome, Interferon, Female, Interferons, Cohort Studie, business, Viral load, Human, Glomerular Filtration Rate
Abstract: Background and aim: The impact of directly acting antiviral agent (DAA) regimens on renal function is not well defined and quite controversial. We evaluated the effect of DAAs on kidney function and the factors associated with an improvement or worsening. Patients and methods: The changes in estimated glomerular filtration rate (eGFR) in a cohort of 403 patients treated with a DAA regimen were evaluated. Results: The overall sustained virological response (SVR12) rate was 98%. The median eGFR progressively increased throughout treatment from 84.54ml/min/1.73m2 (IQR 70.8–97.3) to 88.12ml/min/1.73m2. Conversely, rates of patients with a eGFR more than 60ml/min/1.73m2 progressively increased from 83.1% at baseline to 87.8% at 12weeks post-treatment (p < 0.05). Considering the change in eGFR according to the different factors, a significant improvement in eGFR was observed in the patients without diabetes (p < 0.001), in those with cirrhosis (p < 0.05), in those receiving a Sof-based regimen (p < 0.01) or not receiving RBV (p < 0.05), in those with a baseline eGFR less than 60ml/min/1.73m2 (p < 0.001) and in those with SVR (p < 0.05). An improvement in eGFR (defined as an increase in baseline eGFR of at least 10ml/min/1.73m2) was observed in 148 patients (36.7%). At multivariate analysis, age (aHR 0.96; 95 CI 0.93–0.99, p < 0.01) and a diagnosis of diabetes (aHR 0.02; 95 CI 0.20–0.87, p < 0.05) were inversely and independently associated with improvement in renal function, while the presence of Child–Pugh B cirrhosis at baseline was associated with an improvement in renal function (aHR 3.07; 95 CI 1.49–6.30, p < 0.01). Conclusions: DAAs correlate with an improvement in renal function, underlining the importance of hepatitis C virus eradication to achieve also an improvement in extra-hepatic disorders.
Published: 2019

42. Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection

Author: Riccardo Scotto, Biagio Pinchera, Emanuela Zappulo, Alberto Enrico Maraolo, Nicola Schiano Moriello, Antonio Riccardo Buonomo, Guglielmo Borgia, Ivan Gentile, Scotto, R., Buonomo, A. R., Moriello, N. S., Maraolo, A. E., Zappulo, E., Pinchera, B., Gentile, I., and Borgia, G.
Subjects: Drug, medicine.medical_specialty, Genotype, Sustained Virologic Response, Sofosbuvir, Hepatitis C virus, media_common.quotation_subject, Voxilaprevir, medicine.disease_cause, Direct-acting antiviral, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Glecaprevir, Internal medicine, medicine, Humans, media_common, Pangenotypic drug, Velpatasvir, Pharmacology, business.industry, Pibrentasvir, General Medicine, Hepatitis C, Chronic, Discontinuation, Clinical trial, Real-world, 030220 oncology & carcinogenesis, HCV, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract: Background: Advances in the development of Direct-Acting Antivirals (DAAs), particularly pangenotypic drugs, have led to a high rate of hepatitis C virus (HCV) eradication. Notably, real- world studies have confirmed the efficacy and safety of pangenotypic DAA combinations reported in registration trials. The aim of this study was to review the treatment recommendations, and the efficacy and safety data of anti-HCV pangenotypic drugs reported in registration clinical trials and in recent real-life cohort studies. Methods: We reviewed the efficacy and safety data of pangenotypic anti-HCV drug combinations reported in original articles and in online conference abstracts. Results: Current pangenotypic drug combinations resulted in very high rates of sustained virologic response and few adverse reactions in real-life settings. SVR12 rates in real-life studies ranged from 90-100% depending on the pangenotypic combination, the HCV genotype and the stage of liver disease. Most adverse reactions reported in real-life settings were mild in intensity and rarely led to treatment discontinuation. These results are in accordance with those of clinical trials. Conclusion: Pangenotypic DAAs result in very high rates of sustained virologic responses and are well tolerated. However, they are contraindicated in patients with decompensated cirrhosis or advanced chronic kidney disease who failed previous DDA-based treatment. Further research is required to customize treatment to “unpackage” current DAA combinations and to develop generic drugs against HCV.
Published: 2019

43. Severe Vitamin D deficiency increases mortality among patients with liver cirrhosis regardless of the presence of HCC

Author: Ivan Gentile, Biagio Pinchera, Giuseppe Perruolo, Mariagiovanna Nerilli, Emanuela Zappulo, Riccardo Scotto, Salvatore Nappa, Antonio Riccardo Buonomo, Pietro Formisano, Buonomo, A. R., Scotto, R., Zappulo, E., Nerilli, Mariagiovanna, Pinchera, B., Perruolo, G., Formisano, P., Nappa, S., and Gentile, I.
Subjects: Liver Cirrhosis, Male, Cancer Research, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, Hepatocellular carcinoma, Liver Cirrhosi, Gastroenterology, Severity of Illness Index, General Biochemistry, Genetics and Molecular Biology, vitamin D deficiency, Disease-Free Survival, Cohort Studies, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Overall survival, Humans, In patient, Mortality, Vitamin D, Proportional Hazards Models, Aged, Pharmacology, Cirrhosi, Vitamin D deficiency, Proportional hazards model, business.industry, Risk Factor, Liver Neoplasms, hepatocellular carcinoma, mortality, risk factors, Middle Aged, medicine.disease, digestive system diseases, Liver, Liver Neoplasm, 030220 oncology & carcinogenesis, Proportional Hazards Model, Female, Cohort Studie, business, Research Article, Human
Abstract: Background: The aim of this study was to investigate the association between vitamin D deficiency (10 ng/ml (p=0.003), vitamin D deficiency (p
Published: 2019
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44. Patologie virali tropicali (Flavivirus, Filovirus, Arenavirus, Bunyavirus, Togavirus: Chikungunya

Author: G. Borgia, G. B. Gaeta, I. gentile, N. Coppola, L. Alessio, G. Angarano, S. Babudieri, A. Bartoloni, F. Borgia, F. Borrelli, G. Brancaccio, A. R. Buonomo, B. S. Cacopardo, A. Cascio, C. Contini, S. Esposito, M. Fasano, M. Foggia, M. Gatti, V. Gentile, M. Macera, A. E. Maraolo, A. Marino, C. M. Mastroianni, C. Mussini, G. Nunnari, L. Onorato, M. Pacenti, G. F. Pellicanò, B. Pinchera, G. Pipitone, M. A. Pisaturo, C. Sagnelli, T. A. Santantonio, A. Santoro, A. Saracino, M. Spaziante, M. Spinicci, M. Stanzione, G. Stornaiuolo, G. Taliani, G. Tosone, C. Torti, P. Viale, L. Zammarchi, E. Zappulo, G. Borgia, G.B. Gaeta, I. Gentile, N. Coppola, Borgia, G., Gaeta, G. B., Gentile, I., Coppola, N., Alessio, L., Angarano, G., Babudieri, S., Bartoloni, A., Borgia, F., Borrelli, F., Brancaccio, G., Buonomo, A. R., Cacopardo, B. S., Cascio, A., Contini, C., Esposito, S., Fasano, M., Foggia, M., Gatti, M., Gentile, V., Macera, M., Maraolo, A. E., Marino, A., Mastroianni, C. M., Mussini, C., Nunnari, G., Onorato, L., Pacenti, M., Pellicanò, G. F., Pinchera, B., Pipitone, G., Pisaturo, M. A., Sagnelli, C., Santantonio, T. A., Santoro, A., Saracino, A., Spaziante, M., Spinicci, M., Stanzione, M., Stornaiuolo, G., Taliani, G., Tosone, G., Torti, C., Viale, P., Zammarchi, L., and Zappulo, E.
Published: 2019

45. Unsolved Issues in the Treatment of Spontaneous Peritonitis in Patients with Cirrhosis: Nosocomial Versus Community-acquired Infections and the Role of Fungi

Author: Ivan Gentile, Riccardo Scotto, Alberto Enrico Maraolo, Emanuela Zappulo, Antonio Riccardo Buonomo, Biagio Pinchera, Enrico Maraolo, A., Riccardo Buonomo, A., Zappulo, E., Scotto, R., Pinchera, B., and Gentile, I.
Subjects: Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, medicine.drug_class, Antibiotics, Peritonitis, Spontaneous bacterial peritoniti, Spontaneous fungal peritonitis, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Antibiotic resistance, Spontaneous bacterial peritonitis, medicine, Humans, Multidrug-resistant, Intensive care medicine, Advanced liver disease, Pharmacology, Cross Infection, Cirrhosi, business.industry, Septic shock, General Medicine, Bacterial Infections, medicine.disease, Community-Acquired Infections, Mycoses, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Nosocomial, business, Empiric therapy
Abstract: Introduction:Historically, spontaneous bacterial peritonitis (SBP) has represented one of the most frequent and relevant infectious complications of advanced liver disease, and this is still valid today. Nevertheless, in recent years the role of fungi as causative pathogens of primary peritonitis in patients with cirrhosis has become not negligible. Another issue is linked with the traditional distinction, instrumental in therapeutic choice, between community-acquired and nosocomial forms, according to the onset. Between these two categories, another one has been introduced: the so-called “healthcare-associated infections”.Objective:To discuss the most controversial aspects in the management of SBP nowadays in the light of best available evidence.Methods:A review of recent literature through MEDLINE was performed.Results:The difference between community-acquired and nosocomial infections is crucial to guide empiric antibiotic therapy, since the site of acquisition impact on the likelihood of multidrug-resistant bacteria as causative agents. Therefore, third-generation cephalosporins cannot be considered the mainstay of treatment in each episode. Furthermore, the distinction between healthcare-associated and nosocomial form seems very subtle, especially in areas wherein antimicrobial resistance is widespread, warranting broad-spectrum antibiotic regimens for both. Finally, spontaneous fungal peritonitis is a not common but actually underestimated entity, linked to high mortality. Especially in patients with septic shock and/or failure of an aggressive antibiotic regimen, the empiric addition of an antifungal agent might be considered.Conclusion:Spontaneous bacterial peritonitis is one of the most important complications in patients with cirrhosis. A proper empiric therapy is crucial to have a positive outcome. In this respect, a careful assessment of risk factors for multidrug-resistant pathogens is crucial. Likewise important, mostly in nosocomial cases, is not to overlook the probability of a fungal ascitic infection, namely a spontaneous fungal peritonitis.
Published: 2018

46. Vitamin D deficiency is an independent risk factor and is predictor of infections in patients affected by HCV-related liver cirrhosis

Author: Emanuela Zappulo, Alberto Enrico Maraolo, Guglielmo Borgia, G. Di Filippo, Riccardo Scotto, Antonio Riccardo Buonomo, Biagio Pinchera, Francesco Borrelli, Ivan Gentile, Buonomo, ANTONIO RICCARDO, Zappulo, Emanuela, Scotto, Riccardo, Pinchera, B., Maraolo, ALBERTO ENRICO, Borrelli, F., Di Filippo, G., Borgia, Guglielmo, and Gentile, Ivan
Subjects: medicine.medical_specialty, Endocrinology, Cirrhosis, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, In patient, Risk factor, medicine.disease, business
Published: 2017

47. Epidemiology and risk factors for hepatitis C virus genotypes in a high prevalence region in Italy

Author: Buonomo, A. R., Scotto, R., BIAGIO PINCHERA, Coppola, N., Monari, C., Macera, M., Borgia, G., Gentile, I., Buonomo, Ar, Scotto, R, Pinchera, B, Coppola, N, Monari, C, Macera, M, Borgia, G, Gentile, I., Buonomo, Antonio Riccardo, Scotto, Riccardo, Pinchera, Biagio, Coppola, Nicola, Monari, Caterina, Macera, Margherita, Borgia, Guglielmo, Gentile, Ivan, and Buonomo, ANTONIO RICCARDO
Subjects: Epidemiology, HCV, Risk factor, People who inject drug, Southern Italy
Abstract: Hepatitis C virus (HCV) is globally widespread. Southern Italy is a high prevalence region where the distribution of the HCV genotypes (GTs) is changing. Intravenous drug abuse is the only risk factor associated with a specific HCV GT (GT3). The aim of this study was to evaluate the distribution and the risk factors for specific HCV GTs. A total of 682 patients with measurable serum HCV-RNA were enrolled between January and March 2017. We recorded clinical information and the presence of risk factors for HCV. GT1b was the prevalent genotype in our patients (59.8%). HCV GT1a and GT3 infections were more frequent among patients aged ≤60 years (14.9% vs 2.2%, p

48. Pre-exposure prophylaxis for COVID-19 with Tixagevimab/Cilgavimab in kidney transplant recipients in the Kraken variant (XBB.1.5) era: A Single-center Experience.

Author: Pinchera B, Carrano R, Salemi F, Piccione A, Schettino E, Romano P, Trucillo E, D'Agostino A, Sarno M, Zappulo E, and Gentile I
Subjects: Humans, Male, Middle Aged, Female, Aged, Prospective Studies, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage, Adult, Transplant Recipients, Antiviral Agents therapeutic use, Antiviral Agents administration & dosage, Immunocompromised Host, COVID-19 Drug Treatment, Kidney Transplantation, Pre-Exposure Prophylaxis, SARS-CoV-2 genetics, SARS-CoV-2 immunology, COVID-19 prevention & control
Abstract: Pre-exposure prophylaxis for COVID-19 with Tixagevimab/Cilgavimab in immunocompromised patients has reduced the risk of breakthrough infection, disease, hospitalization, and COVID-19 related mortality. However, the advent of the Kraken variant (XBB.1.5) has limited the use of this monoclonal antibody, based on poor efficacy in in vitro studies The objective of the study was to evaluate the risk of breakthrough infection, symptomatic disease, hospitalization, intensive care admission, and COVID-19 related death in kidney transplant recipients receiving pre-exposure prophylaxis with Tixagevimab/Cilgavimab for COVID-19 in the era of the Kraken variant (XBB.1.5). In a prospective, observational study, we enrolled kidney transplant patients undergoing pre-exposure prophylaxis for COVID-19 with Tixagevimab/Cilgavimab at the Division of Infectious Diseases of Federico II University of Naples from February 2023 to August 2023. Each patient subsequently underwent a six-month follow-up with symptom monitoring and surveillance nasopharyngeal swab for SARS-CoV-2 RNA detection every 30 days, regardless of symptoms. Thirty-four kidney transplant patients were enrolled, and in the follow-up period only one tested positive for the nasopharyngeal swab for SARSCoV-2 research with asymptomatic infection and virological recovery on the eighth day after diagnosis of infection. Therefore, no patient developed disease, no patient needed hospitalization, and no death occurred. No adverse drug reaction to Tixagevimab/Cilgavimab occurred. Our data, although derived from a limited and uncontrolled sample, show the potential of Tixagevimab/Cilgavimab as a valid and viable therapeutic strategy in pre-exposure prophylaxis for immunocompromised patients. These findings highlight the importance of conducting clinical studies on this topic.
Published: 2024

49. Urinary Tract Infections in Kidney Transplant Patients: An Open Challenge-Update on Epidemiology, Risk Factors and Management.

Author: Pinchera B, Trucillo E, D'Agostino A, and Gentile I
Abstract: Urinary tract infections are one of the main complications in kidney transplant patients, with a significant impact on graft function and survival. In fact, it is estimated that up to 74% of kidney transplant patients experience at least one episode of UTIs in the first year after transplantation, with an increased risk of graft loss and an increased risk of mortality. Several risk factors have been identified, such as female gender, old age, diabetes mellitus, immunosuppression, pre-transplant UTIs, urinary tract abnormalities, and prolonged dialysis. The worsening burden of antimicrobial resistance is also in itself a risk factor and a major complication in evolution and management. The management of prophylaxis, asymptomatic bacteriuria, and UTIs is still an open challenge, with some points to be clarified. Faced with such scenarios, our review aimed to evaluate the current epidemiology, examine the risk factors, and consider all the possibilities and methods of management, giving a current view and evaluation of the topic., Competing Interests: Ivan Gentile has acted as a consultant for MSD, AbbVie, Gilead, Abbott, Pfizer, GSK, AstraZeneca, Basilea, SOBI, Nordic/InfectoPharm, Angelini, Moderna, Shionogi, and Advanz Pharma. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Published: 2024
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50. Bulevirtide Treatment of Hepatitis Delta Virus Infection in a Kidney Transplant Recipient: A Case Report.

Author: Pinchera B, Carrano R, Salemi F, Piccione A, Schettino E, Cuccurullo F, Buonomo AR, and Gentile I
Subjects: Humans, Male, Adult, Treatment Outcome, Immunosuppressive Agents adverse effects, Immunosuppressive Agents therapeutic use, RNA, Viral blood, Drug Interactions, Viral Load, Hepatitis D drug therapy, Hepatitis D diagnosis, Hepatitis D virology, Hepatitis B diagnosis, Hepatitis B drug therapy, Hepatitis B virology, Kidney Transplantation adverse effects, Antiviral Agents therapeutic use, Coinfection drug therapy
Abstract: Objectives: Hepatitis delta virus infection poses a significant challenge in solid-organ transplant recipients due to its aggressive nature and limited therapeutic options. Bulevirtide is a novel antiviral agent approved by the European Medicines Agency in 2020 for the treatment of hepatitis delta virus infection, but limited data are available on its use in solid-organ transplant recipients., Materials and Methods: We present a case report of a 42-year-old male kidney transplant patient with coinfection of hepatitis B virus and hepatitis delta virus who was treated with bulevirtide over a 6-month period., Results: The patient exhibited virological and bioc-hemical responses and achieved undetectable serum hepatitis delta virus RNA and normalized transaminase levels within 2 months of therapy. Bulevirtide was well tolerated, with only mild tenderness at the injection site and mild asthenia. Pharmacological evaluation indicated potential drug interactions with tacrolimus, which led to increased serum levels of tacrolimus, whereas everolimus levels remained stable., Conclusions: This case emphasizes the importance of an individualized treatment approach and highlights the potential efficacy of bulevirtide in solid-organ transplant recipients with hepatitis delta virus infection. Further research is warranted to better understand manage-ment factors in this patient population.
Published: 2024
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