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9 results on '"Rosa, Regis G."'

1. Effect of Apixaban on Clinical Outcomes in Outpatients With COVID-19: The APOLLO Randomized Clinical Trial

Author

de Barros e Silva, Pedro Gabriel Melo, Macedo, Ariane Vieira Scarlatelli, Bronhara, Bruna, Damiani, Lucas Petri, Mazza Barbosa, Lilian, Lopes, Nathália Rodrigues, Suiama, Mayra Akimi, Antunes, Murillo O., Gonçalves, Mariana Raquel, Gebara, Otávio Celso Eluf, de Aquino Martins, Priscilla, Ribeiro, Mariana Galvão, de Moura Xavier de Moraes, João Batista, Aguiar, Valéria Cristina Resende, Cavalcanti, Alexandre B., Rosa, Regis G., Berwanger, Otavio, Veiga, Viviane C., Azevedo, Luciano C.P., Ramacciotti, Eduardo, Granger, Christopher B., Alexander, John H., Avezum, Alvaro, and Lopes, Renato D.

Published
2024
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2. Antisense therapy to block the Kallikrein-kinin pathway in COVID-19: The ASKCOV randomized controlled trial

Author

Zampieri, Fernando G., Westphal, Glauco Adrieno, Santos, Maria Adelaide Dos, Gomes, Samara P.C., Gomes, Jackeline O., Negrelli, Karina L., Santos, Renato H.N., Ishihara, Luciana M., Miranda, Tamiris A., Laranjeira, Ligia N., Valeis, Nanci, Santucci, Eliana Vieira, de Souza Dantas, Vicente Cés, Gebara, Otávio, Cohn, Danny M., Buchele, Gustavo, Janiszewski, Mariano, de Freitas, Flávio Geraldo, Dal-Pizzol, Felipe, de Matos Soeiro, Alexandre, Berti, Isabele Ribeiro, Germano, Almir, Schettini, Daniel Almeida, Rosa, Regis G., Falavigna, Maicon, Veiga, Viviane C., Azevedo, Luciano C.P., Damiani, Lucas P., Machado, Flávia R., and Cavalcanti, Alexandre B.

Abstract

To assess the effect of antisense therapy to block kallikrein-kinin pathway in COVID-19 patients.

Published
2024
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3. Randomized clinical trial to evaluate a routine full anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) admitted to hospital: Rationale and design of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV trial.

Author

Lopes, Renato D., de Barros e Silva, Pedro Gabriel Melo, Furtado, Remo H.M., Macedo, Ariane Vieira Scarlatelli, Ramacciotti, Eduardo, Damini, Lucas Petri, Bronhara, Bruna, Cavalcanti, Alexandre B., Rosa, Regis G., Azevedo, Luciano C.P., Veiga, Viviane C., Machado, Flávia R, Ritt, Luiz Eduardo, Martins, Priscilla de Aquino, Alexander, John H., Avezum, Alvaro, Berwanger, Otavio, and Coalition COVID-19 Brazil IV Investigators

Abstract

Background: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation.Design: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria.Summary: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels. [ABSTRACT FROM AUTHOR]

Published
2021
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4. Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial

Author

Lopes, Renato D, de Barros e Silva, Pedro Gabriel Melo, Furtado, Remo H M, Macedo, Ariane Vieira Scarlatelli, Bronhara, Bruna, Damiani, Lucas Petri, Barbosa, Lilian Mazza, de Aveiro Morata, Júlia, Ramacciotti, Eduardo, de Aquino Martins, Priscilla, de Oliveira, Aryadne Lyrio, Nunes, Vinicius Santana, Ritt, Luiz Eduardo Fonteles, Rocha, Ana Thereza, Tramujas, Lucas, Santos, Sueli V, Diaz, Dario Rafael Abregu, Viana, Lorena Souza, Melro, Lívia Maria Garcia, de Alcântara Chaud, Mariana Silveira, Figueiredo, Estêvão Lanna, Neuenschwander, Fernando Carvalho, Dracoulakis, Marianna Deway Andrade, Lima, Rodolfo Godinho Souza Dourado, de Souza Dantas, Vicente Cés, Fernandes, Anne Cristine Silva, Gebara, Otávio Celso Eluf, Hernandes, Mauro Esteves, Queiroz, Diego Aparecido Rios, Veiga, Viviane C, Canesin, Manoel Fernandes, de Faria, Leonardo Meira, Feitosa-Filho, Gilson Soares, Gazzana, Marcelo Basso, Liporace, Idelzuíta Leandro, de Oliveira Twardowsky, Aline, Maia, Lilia Nigro, Machado, Flávia Ribeiro, de Matos Soeiro, Alexandre, Conceição-Souza, Germano Emílio, Armaganijan, Luciana, Guimarães, Patrícia O, Rosa, Regis G, Azevedo, Luciano C P, Alexander, John H, Avezum, Alvaro, Cavalcanti, Alexandre B, and Berwanger, Otavio

Abstract

COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population.

Published
2021
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5. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial

Author

Furtado, Remo H M, Berwanger, Otavio, Fonseca, Henrique A, Corrêa, Thiago D, Ferraz, Leonardo R, Lapa, Maura G, Zampieri, Fernando G, Veiga, Viviane C, Azevedo, Luciano C P, Rosa, Regis G, Lopes, Renato D, Avezum, Alvaro, Manoel, Airton L O, Piza, Felipe M T, Martins, Priscilla A, Lisboa, Thiago C, Pereira, Adriano J, Olivato, Guilherme B, Dantas, Vicente C S, Milan, Eveline P, Gebara, Otavio C E, Amazonas, Roberto B, Oliveira, Monalisa B, Soares, Ronaldo V P, Moia, Diogo D F, Piano, Luciana P A, Castilho, Kleber, Momesso, Roberta G R A P, Schettino, Guilherme P P, Rizzo, Luiz Vicente, Neto, Ary Serpa, Machado, Flávia R, and Cavalcanti, Alexandre B

Abstract

The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.

Published
2020
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6. Cohort Study of the Impact of Time to Antibiotic Administration on Mortality in Patients with Febrile Neutropenia

Author

Rosa, Regis G. and Goldani, Luciano Z.

Abstract

ABSTRACTThe time to antibiotic administration (TTA) has been proposed as a quality-of-care measure in febrile neutropenia (FN); however, few data regarding the impact of the TTA on the mortality of adult cancer patients with FN are available. The objective of this study was to determine whether the TTA is a predictor of mortality in adult cancer patients with FN. A prospective cohort study of all consecutive cases of FN, evaluated from October 2009 to August 2011, at a single tertiary referral hospital in southern Brazil was performed. The TTA was assessed as a predictive factor for mortality within 28 days of FN onset using the Cox proportional hazards model. Kaplan-Meier curves were used for an assessment of the mortality rates according to different TTAs; the log-rank test was used for between-group comparisons. In total, 307 cases of FN (169 subjects) were evaluated. During the study period, there were 29 deaths. In a Cox regression analysis, the TTA was independently associated with mortality within 28 days (hazard ratio [HR], 1.18; 95% confidence interval [CI], 1.10 to 1.26); each increase of 1 h in the TTA raised the risk of mortality within 28 days by 18%. Patients with FN episodes with a TTA of ≤30 min had lower 28-day mortality rates than those with a TTA of between 31 min and 60 min (3.0% versus 18.1%; log-rank P= 0.0002). Early antibiotic administration was associated with higher survival rates in the context of FN. Efforts should be made to ensure that FN patients receive effective antibiotic therapy as soon as possible. A target of 30 min to the TTA should be adopted for cancer patients with FN.

Published
2014
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7. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): a double-blind, multicentre, randomised, controlled trial

Author

Avezum, Álvaro, Oliveira, Gustavo B F, Oliveira, Haliton, Lucchetta, Rosa C, Pereira, Valéria F A, Dabarian, André L, D´O Vieira, Ricardo, Silva, Daniel V, Kormann, Adrian P M, Tognon, Alexandre P, De Gasperi, Ricardo, Hernandes, Mauro E, Feitosa, Audes D M, Piscopo, Agnaldo, Souza, André S, Miguel, Carlos H, Nogueira, Vinicius O, Minelli, César, Magalhães, Carlos C, Morejon, Karen M L, Bicudo, Letícia S, Souza, Germano E C, Gomes, Marco A M, Fo, José J F Raposo, Schwarzbold, Alexandre V, Zilli, Alexandre, Amazonas, Roberto B, Moreira, Frederico R, Alves, Lucas B O, Assis, Silvia R L, Neves, Precil D M M, Matuoka, Jessica Y, Boszczowski, Icaro, Catarino, Daniela G M, Veiga, Viviane C, Azevedo, Luciano C P, Rosa, Regis G, Lopes, Renato D, Cavalcanti, Alexandre B, and Berwanger, Otavio

Abstract

Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers.

Published
2022
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8. Risk factors for multidrug-resistant bacteremia in hospitalized cancer patients with febrile neutropenia: A cohort study.

Author

Rosa, Regis G., Goldani, Luciano Z., and dos Santos, Rodrigo P.

Abstract

We conducted a prospective cohort study in a single tertiary hospital with the aim of assessing predictors of multidrug-resistant bacteremia in 307 cases of febrile neutropenia in adult patients with cancer. On multivariate analysis using stepwise logistic regression, age (P = .009), duration of neutropenia (P = .022), and presence of an indwelling central venous catheter (P = .022) were associated with bloodstream infection by multidrug-resistant bacteria. [Copyright &y& Elsevier]

Published
2014
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9. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial

Author

Veiga, Viviane C, Prats, João A G G, Farias, Danielle L C, Rosa, Regis G, Dourado, Leticia K, Zampieri, Fernando G, Machado, Flávia R, Lopes, Renato D, Berwanger, Otavio, Azevedo, Luciano C P, Avezum, Álvaro, Lisboa, Thiago C, Rojas, Salomón S O, Coelho, Juliana C, Leite, Rodrigo T, Carvalho, Júlio C, Andrade, Luis E C, Sandes, Alex F, Pintão, Maria C T, Castro, Claudio G, Santos, Sueli V, de Almeida, Thiago M L, Costa, André N, Gebara, Otávio C E, de Freitas, Flávio G Rezende, Pacheco, Eduardo S, Machado, David J B, Martin, Josiane, Conceicão, Fábio G, Siqueira, Suellen R R, Damiani, Lucas P, Ishihara, Luciana M, Schneider, Daniel, de Souza, Denise, Cavalcanti, Alexandre B, and Scheinberg, Phillip

Abstract

ObjectiveTo determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19).DesignRandomised, open label trial.SettingNine hospitals in Brazil, 8 May to 17 July 2020.ParticipantsAdults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group.InterventionsTocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64).Main outcome measureThe primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met.ResultsA total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab.ConclusionsIn patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality.Trial registrationClinicalTrials.gov NCT04403685.

Published
2021
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