39 results on '"Schwarzbold AV"'
Search Results
2. Palliative care and COVID-19: acknowledging past mistakes to forge a better future.
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de Andrade CRM, Luz FST, de Oliveira NR, Kopittke L, Santa Rosa LMM, Gomes AGDR, Bartolazzi F, Francisco SC, da Costa FR, Jorge AO, Cimini CCR, Carneiro M, Ruschel KB, Schwarzbold AV, Ponce D, Ferreira MAP, Guimarães Júnior MH, Silveira DV, Aranha FG, de Carvalho RLR, de Godoy MF, Viana LMP, Hirakata VN, Bicalho MAC, and Marcolino MS
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Context: COVID-19 induces complex distress across physical, psychological, and social realms and palliative care (PC) has the potential to mitigate this suffering significantly., Objectives: To describe the clinical characteristics and outcomes of COVID-19 patients with an indication of PC, compared to patients who had no indication, in different pandemic waves., Methods: This retrospective multicenter observational cohort included patients from 40 hospitals, admitted from March 2020 to August 2022. Patients who had an indication of palliative care (PC) described in their medical records were included in the palliative care group (PCG), while those who had no such indication in their medical records were allocated to the non-palliative care group (NPCG)., Results: Out of 21,158 patients, only 6.7% had indication for PC registered in their medical records. The PCG was older, had a higher frequency of comorbidities, exhibited higher frailty, and had a higher prevalence of clinical complications and mortality (81.4% vs. 17.7%, p < 0.001), when compared to the NPCG. Regarding artificial life support, the PCG had a higher frequency of dialysis (20.4% vs. 10.1%, p < 0.001), invasive mechanical ventilation (48.2% vs. 26.0%, p < 0.001) and admission to the intensive care unit (53.6% vs. 35.4%, p < 0.001). These differences were consistent across all three waves., Conclusion: A low proportion of patients received PC. Patients in PCG were more fragile, had more clinical complications, and had a higher mortality. On the contrary to our expectations, they received more artificial life support in all three waves. Taken together, these findings suggest that decisions regarding PC indication were made too late, within a context of end-of-life and therapeutic failure., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Andrade, Luz, Oliveira, Kopittke, Santa Rosa, Gomes, Bartolazzi, Francisco, Costa, Jorge, Cimini, Carneiro, Ruschel, Schwarzbold, Ponce, Ferreira, Guimarães Júnior, Silveira, Aranha, Carvalho, Godoy, Viana, Hirakata, Bicalho and Marcolino.)
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- 2024
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3. Genomic surveillance and vaccine response to the dominant SARS-CoV-2 XBB lineage in Rio Grande do Sul.
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Piccoli BC, Y Castro TR, Tessele LF, Casarin BC, Seerig AP, Vieira AA, Santos VT, Schwarzbold AV, and Trindade PA
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- Humans, Brazil epidemiology, Female, Male, Middle Aged, Adult, Aged, Phylogeny, Young Adult, Adolescent, Genomics methods, SARS-CoV-2 genetics, SARS-CoV-2 immunology, COVID-19 epidemiology, COVID-19 immunology, COVID-19 virology, COVID-19 prevention & control, COVID-19 Vaccines immunology, Genome, Viral
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The COVID-19 pandemic has been marked by novel viral variants, posing challenges to global public health. Recombination, a viral evolution mechanism, is implicated in SARS-CoV-2's ongoing evolution. The XBB recombinant lineage, known for evading antibody-mediated immunity, exhibits higher transmissibility without increased disease severity. We investigated the prevalence and genomic features of XBB in SARS-CoV-2-positive cases in Rio Grande do Sul (RS), Brazil. We sequenced 357 samples from epidemiological weeks (EW) 47/2022 to 17/2023, and included 389 publicly available sequences. Clinical and epidemiological data were obtained from DATASUS, e-SUS, and SIVEP GRIPE (data recording systems of the Brazilian Ministry of Health). Of these, 143 were classified as XBB and 586 were other Omicron lineages. In March 2023 (EW 10), XBB became dominant, accounting for 83.3% of cases. 97.7% of XBB-infected patients successfully recovered from the infection, with a low mortality rate (2.3%). Even after receiving three vaccine doses and having been previously infected, 59.5% of the patients experienced reinfection with XBB. However, for 54% of the individuals, the interval between their XBB infection and the last vaccine dose exceeded one year, potentially leading to a decline in antibody levels. In addition, we identified 90 mutations in RS circulating XBB, spread throughout the genome, notably in the Spike protein region associated with immune resistance. This study provides insights into the dynamics and impact of a recombinant variant becoming predominant for the first time in the state. Continued surveillance of SARS-CoV-2 genomic evolution is crucial for effective public health management., (© 2024. The Author(s).)
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- 2024
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4. AB 2 CO risk score for in-hospital mortality of COVID-19 patients admitted to intensive care units.
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Gomes VMR, Pires MC, Delfino Pereira P, Schwarzbold AV, Gomes AGDR, Pessoa BP, Cimini CCR, Rios DRA, Anschau F, Nascimento FJM, Grizende GMS, Vietta GG, Batista JDL, Ruschel KB, Carneiro M, Reis MA, Bicalho MAC, Porto PF, Reis PPD, Araújo SF, Nobre V, and Marcolino MS
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- Humans, Male, Aged, Retrospective Studies, Female, Middle Aged, Brazil epidemiology, Pulmonary Disease, Chronic Obstructive physiopathology, Pulmonary Disease, Chronic Obstructive therapy, Risk Assessment methods, Hospital Mortality, Obesity complications, Risk Factors, Age Factors, COVID-19 epidemiology, Intensive Care Units statistics & numerical data, Respiration, Artificial statistics & numerical data
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Purpose: To develop a mortality risk score for COVID-19 patients admitted to intensive care units (ICU), and to compare it with other existing scores., Materials and Methods: This retrospective observational study included consecutive adult patients with laboratory-confirmed COVID-19 admitted to ICUs of 18 hospitals from nine Brazilian cities, from September 2021 to July 2022. Potential predictors were selected based on the literature review. Generalized Additive Models were used to examine outcomes and predictors. LASSO regression was used to derive the mortality score., Results: From 558 patients, median age was 69 years (IQR 58-78), 56.3 % were men, 19.7 % required mechanical ventilation (MV), and 44.8 % died. The final model comprised six variables: age, pO
2 /FiO2 , respiratory function (respiratory rate or if in MV), chronic obstructive pulmonary disease, and obesity. The AB2 CO had an AUROC of 0.781 (95 % CI 0.744 to 0.819), good overall performance (Brier score = 0.191) and an excellent calibration (slope = 1.063, intercept = 0.015, p-value = 0.834). The model was compared with other scores and displayed better discrimination ability than the majority of them., Conclusions: The AB2 CO score is a fast and easy tool to be used upon ICU admission., Competing Interests: Declaration of competing interest The author(s) declared no potential conflicts of interest concerning the research, authorship, and/or publication and/or competing financial of this article., (Copyright © 2024 Elsevier Ltd. All rights reserved.)- Published
- 2024
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5. Patients hospitalized with active tuberculosis and Covid-19 coinfection: A matched case-control from the Brazilian Covid-19 Registry.
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Carvalho RLR, Aguiar GG, Moreira JFB, Pereira DN, Augusto VM, Schwarzbold AV, Matos CC, Rios DRA, Costa FR, Anschau F, Chatkin JM, Ruschel KB, Carneiro M, Oliveira NR, Paraíso PG, Aguiar RLO, Grizende GMS, and Marcolino MS
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- Humans, Male, Brazil epidemiology, Case-Control Studies, Female, Middle Aged, Adult, Registries, Tuberculosis complications, Tuberculosis epidemiology, Hospital Mortality, Pandemics, Aged, Pneumonia, Viral complications, Pneumonia, Viral epidemiology, Betacoronavirus, Coronavirus Infections complications, Coronavirus Infections epidemiology, COVID-19 complications, SARS-CoV-2, Coinfection epidemiology, Hospitalization statistics & numerical data
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Although control of Covid-19 has improved, the virus continues to cause infections, such as tuberculosis, that is still endemic in many countries, representing a scenario of coinfection. To compare Covid-19 clinical manifestations and outcomes between patients with active tuberculosis infection and matched controls. This is a matched case-control study based on data from the Brazilian Covid-19 Registry, in hospitalized patients aged 18 or over with laboratory confirmed Covid-19 from March 1, 2020, to March 31, 2022. Cases were patients with tuberculosis and controls were Covid-19 patients without tuberculosis. From 13,636 Covid-19, 36 also had active tuberculosis (0.0026%). Pulmonary fibrosis (5.6% vs 0.0%), illicit drug abuse (30.6% vs 3.0%), alcoholism (33.3% vs 11.9%) and smoking (50.0% vs 9.7%) were more common among patients with tuberculosis. They also had a higher frequency of nausea and vomiting (25.0% vs 10.4%). There were no significant differences in in-hospital mortality, mechanical ventilation, need for dialysis and ICU stay. Patients with TB infection presented a higher frequency of pulmonary fibrosis, abuse of illicit drugs, alcoholism, current smoking, symptoms of nausea and vomiting. The outcomes were similar between them.
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- 2024
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6. Clinical characteristics and outcomes in COVID-19 in kidney transplant recipients: a propensity score matched cohort study.
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Delfino-Pereira P, Ventura VDGJ, Pires MC, Ponce D, do Carmo GAL, do Carmo LPF, de Paiva BBM, Schwarzbold AV, Gomes AGDR, de Castro BM, Polanczyk CA, Cimini CCR, de Lima DA, de Sousa FC, Bartolazzi F, Vietta GG, Vianna HR, Chatkin JM, Ruschel KB, Kopittke L, de Castro LC, Carneiro M, Dos Reis PP, and Marcolino MS
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Patients with chronic kidney disease (CKD), especially those on dialysis or who have received a kidney transplant (KT), are considered more vulnerable to severe COVID-19. This susceptibility is attributed to advanced age, a higher frequency of comorbidities, and the chronic immunosuppressed state, which may exacerbate their susceptibility to severe outcomes. Therefore, our study aimed to compare the clinical characteristics and outcomes of COVID-19 in KT patients with those on chronic dialysis and non-CKD patients in a propensity score-matched cohort study. This multicentric retrospective cohort included adult COVID-19 laboratory-confirmed patients admitted from March/2020 to July/2022, from 43 Brazilian hospitals. The primary outcome was in-hospital mortality. Propensity score analysis matched KT recipients with controls - patients on chronic dialysis and those without CKD (within 0.25 standard deviations of the logit of the propensity score) - according to age, sex, number of comorbidities, and admission year. This study included 555 patients: 163 KT, 146 on chronic dialysis, and 249 non-CKD patients (median age 57 years, 55.2% women). With regards to clinical outcomes, chronic dialysis patients had a higher prevalence of acute heart failure, compared to KT recipients, furthermore, both groups presented high in-hospital mortality, 34.0 and 28.1%, for KT and chronic dialysis patients, respectively. When comparing KT and non-CKD patients, the first group had a higher incidence of in-hospital dialysis (26.4% vs . 8.8%, p < 0.001), septic shock (24.1% vs . 12.0%, p = 0.002), and mortality (32.5% vs . 23.3%, p = 0.039), in addition to longer time spent in the intensive care unit (ICU). In this study, chronic dialysis patients presented a higher prevalence of acute heart failure, compared to KT recipients, whereas KT patients had a higher frequency of complications than those without CKD, including septic shock, dialysis during hospitalization, and in-hospital mortality as well as longer time spent in the ICU., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Delfino-Pereira, Ventura, Pires, Ponce, Carmo, Carmo, Paiva, Schwarzbold, Gomes, Castro, Polanczyk, Cimini, Lima, Sousa, Bartolazzi, Vietta, Vianna, Chatkin, Ruschel, Kopittke, Castro, Carneiro, Reis and Marcolino.)
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- 2024
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7. Corrigendum: Assessment of risk scores to predict mortality of COVID-19 patients admitted to the intensive care unit.
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Nogueira MCA, Nobre V, Pires MC, Ramos LEF, Ribeiro YCNMB, Aguiar RLO, Vigil FMB, Gomes VMR, Santos CO, Miranda DM, Durães PAA, da Costa JM, Schwarzbold AV, Gomes AGDR, Pessoa BP, Matos CC, Cimini CCR, de Carvalho CA, Ponce D, Manenti ERF, Cenci EPA, Anschau F, Costa FCC, Nascimento FJM, Bartolazzi F, Grizende GMS, Vianna HR, Nepomuceno JC, Ruschel KB, Zandoná LB, de Castro LC, Souza MD, Carneiro M, Bicalho MAC, Vilaça MDN, Bonardi NPF, de Oliveira NR, Lutkmeier R, Francisco SC, Araújo SF, Delfino-Pereira P, and Marcolino MS
- Abstract
[This corrects the article DOI: 10.3389/fmed.2023.1130218.]., (Copyright © 2024 Nogueira, Nobre, Pires, Ramos, Ribeiro, Aguiar, Vigil, Gomes, Santos, Miranda, Durães, Costa, Schwarzbold, Gomes, Pessoa, Matos, Cimini, Carvalho, Ponce, Manenti, Cenci, Anschau, Costa, Nascimento, Bartolazzi, Grizende, Vianna, Nepomuceno, Ruschel, Zandoná, Castro, Souza, Carneiro, Bicalho, Vilaça, Bonardi, Oliveira, Lutkmeier, Francisco, Araújo, Delfino-Pereira and Marcolino.)
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- 2024
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8. Introduction, Dispersal, and Predominance of SARS-CoV-2 Delta Variant in Rio Grande do Sul, Brazil: A Retrospective Analysis.
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Y Castro TR, Piccoli BC, Vieira AA, Casarin BC, Tessele LF, Salvato RS, Gregianini TS, Martins LG, Resende PC, Pereira EC, Moreira FRR, de Jesus JG, Seerig AP, Lobato MAO, de Campos MMA, Goularte JS, da Silva MS, Demoliner M, Filippi M, Pereira VMAG, Schwarzbold AV, Spilki FR, and Trindade PA
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Mutations in the SARS-CoV-2 genome can alter the virus' fitness, leading to the emergence of variants of concern (VOC). In Brazil, the Gamma variant dominated the pandemic in the first half of 2021, and from June onwards, the first cases of Delta infection were documented. Here, we investigate the introduction and dispersal of the Delta variant in the RS state by sequencing 1077 SARS-CoV-2-positive samples from June to October 2021. Of these samples, 34.7% were identified as Gamma and 65.3% as Delta. Notably, 99.2% of Delta sequences were clustered within the 21J lineage, forming a significant Brazilian clade. The estimated clock rate was 5.97 × 10
-4 substitutions per site per year. The Delta variant was first reported on 17 June in the Vinhedos Basalto microregion and rapidly spread, accounting for over 70% of cases within nine weeks. Despite this, the number of cases and deaths remained stable, possibly due to vaccination, prior infections, and the continued mandatory mask use. In conclusion, our study provides insights into the Delta variant circulating in the RS state, highlighting the importance of genomic surveillance for monitoring viral evolution, even when the impact of new variants may be less severe in a given region.- Published
- 2023
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9. Incidence of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Illness in Infants in Low- and Middle-Income Regions During the Coronavirus Disease 2019 Pandemic.
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Fry S, Chokephaibulkit K, Pallem S, Henry O, Pu Y, Akawung A, Kim JH, Yanni E, Tullio AN, Aurpibul L, Lee CMF, Ceballos A, Zaman K, Abadía de Regalado I, Ahmed K, Arias Fernandez DA, Taher SW, Caccavo J, Coutinho CM, D'Andrea Nores U, De León T, D'Silva EC, De Bernardi M, Dieser P, Falaschi A, Flores Acosta CDC, Gentile A, Teo IH, Kotze S, López-Medina E, Luca R, Lucion MF, Mantaring JBIV, Marín B, Moelo M, Mussi-Pinhata MM, Pinto J, Puthanakit T, Reyes O, Roa MF, Rodriguez Brieschke MT, Rodriguez CE, Rodriguez Niño JN, Schwarzbold AV, Sierra Garcia A, Sivapatham L, Soon R, Tinoco JC, Velásquez Penagos JA, and Dos Santos G
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Background: Incidence data of respiratory syncytial virus-associated lower respiratory tract illness (RSV-LRTI) are sparse in low- and middle-income countries (LMICs). We estimated RSV-LRTI incidence rates (IRs) in infants in LMICs using World Health Organization case definitions., Methods: This prospective cohort study, conducted in 10 LMICs from May 2019 to October 2021 (largely overlapping with the coronavirus disease 2019 [COVID-19] pandemic), followed infants born to women with low-risk pregnancies for 1 year from birth using active and passive surveillance to detect potential LRTIs, and quantitative reverse-transcription polymerase chain reaction on nasal swabs to detect RSV., Results: Among 2094 infants, 32 (1.5%) experienced an RSV-LRTI (8 during their first 6 months of life, 24 thereafter). Seventeen (0.8%) infants had severe RSV-LRTI and 168 (8.0%) had all-cause LRTI. IRs (95% confidence intervals [CIs]) of first RSV-LRTI episode were 1.0 (.3-2.3), 0.8 (.3-1.5), and 1.6 (1.1-2.2) per 100 person-years for infants aged 0-2, 0-5, and 0-11 months, respectively. IRs (95% CIs) of the first all-cause LRTI episode were 10.7 (8.1-14.0), 11.7 (9.6-14.0), and 8.7 (7.5-10.2) per 100 person-years, respectively. IRs varied by country (RSV-LRTI: 0.0-8.3, all-cause LRTI: 0.0-49.6 per 100 person-years for 0- to 11-month-olds)., Conclusions: RSV-LRTI IRs in infants in this study were relatively low, likely due to reduced viral circulation caused by COVID-19-related nonpharmaceutical interventions., Clinical Trials Registration: NCT03614676., Competing Interests: Potential conflicts of interest. J. H. K., A. N. T., E. Y., O. H., Y. P., and G. D. S. were employees of GSK when the study was designed, initiated, or conducted. J. H. K., A. N. T., E. Y., O. H., and G. D. S. declare they hold or held shares in GSK as part of their remuneration. A. A. and S. P. work for Keyrus Life Science on behalf of GSK. C. d. C. F. A. received payment from GSK for participation in the study, patient consultations, and ultrasounds. E. L. M. declares research grants from GSK, SP, Janssen, MSD, and the World Health Organization. T. P. received research grants from GSK through her institution. C. M. F. L. received consulting fees and payment for travel expenses for an investigator meeting from GSK and reports payment by GSK to Clinical Research Malaysia. A. V. S. declares research grant from GSK and grants or contracts from MSD, AstraZeneca, Esperion, Clover Biopharm, and F2G. L. S. declares payments from GSK to her institution as a research site for this study. R. S. reports study management and funding as principal investigator from GSK. J. B. V. M. declares payment received for a speaker's bureau for Wyeth Nutrition and participation as Chair of institutional review board, Chair of the Department of Health Single Joint Ethics review board, Chair of the Philippine Health Research Ethics Network, and member of the Philippine Health Technology Assessment Council. M. M. M. P. declares payment from GSK to her institution as a research site for this study. All other authors report no potential conflicts., (© GSK 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2023
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10. Pipeline validation for the identification of antimicrobial-resistant genes in carbapenem-resistant Klebsiella pneumoniae.
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Vieira AA, Piccoli BC, Y Castro TR, Casarin BC, Tessele LF, Martins RCR, Schwarzbold AV, and Trindade PA
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- Reproducibility of Results, Benchmarking, Carbapenems pharmacology, Klebsiella pneumoniae genetics, Carbapenem-Resistant Enterobacteriaceae genetics
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Antimicrobial-resistant Klebsiella pneumoniae is a global threat to healthcare and an important cause of nosocomial infections. Antimicrobial resistance causes prolonged treatment periods, high mortality rates, and economic impacts. Whole Genome Sequencing (WGS) has been used in laboratory diagnosis, but there is limited evidence about pipeline validation to parse generated data. Thus, the present study aimed to validate a bioinformatics pipeline for the identification of antimicrobial resistance genes from carbapenem-resistant K. pneumoniae WGS. Sequences were obtained from a publicly available database, trimmed, de novo assembled, mapped to the K. pneumoniae reference genome, and annotated. Contigs were submitted to different tools for bacterial (Kraken2 and SpeciesFinder) and antimicrobial resistance gene identification (ResFinder and ABRicate). We analyzed 201 K. pneumoniae genomes. In the bacterial identification by Kraken2, all samples were correctly identified, and in SpeciesFinder, 92.54% were correctly identified as K. pneumoniae, 6.96% erroneously as Pseudomonas aeruginosa, and 0.5% erroneously as Citrobacter freundii. ResFinder found a greater number of antimicrobial resistance genes than ABRicate; however, many were identified more than once in the same sample. All tools presented 100% repeatability and reproducibility and > 75% performance in other metrics. Kraken2 was more assertive in recognizing bacterial species, and SpeciesFinder may need improvements., (© 2023. Springer Nature Limited.)
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- 2023
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11. Safety of spinal anesthesia in pregnant vaccinated with one or two doses of the BNT162b2 vaccine: A retrospective observational cohort study.
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Yamada EJ, Petró GD, Rohden GB, Marques CT, Schwarzbold AV, and Backes DS
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Purpose: To evaluate the safety of spinal anesthesia in pregnant women who underwent cesarean section during the Covid-19 pandemia and were immunized with the BNT162b2 vaccine., Methods: Historical cohort study that included three groups: non-vaccinated pregnant with no history of acute or previous Covid-19 [NV ( n = 70)], vaccinated with one dose [1D ( n = 65)] or two doses of BNT162b2 [2D ( n = 45)], who underwent cesarean section with spinal anesthesia. Variables with normal distribution were analyzed with ANOVA. When one or more groups had non-normal distribution, the Kruskal-Wallis test was used. For categorical variables, the chi-square test or Kruskal-Wallis test was performed. When any variable had a frequency of less than five, the two-tailed Fisher's exact test with the Freeman-Halton extension was used. The significance level considered was p < .05., Results: Apparently there is no interaction between BNT162b2 and the drugs most commonly used in spinal anesthesia for cesarean delivery. Conclusion: Performing spinal anesthesia in patients immunized with BNT162b2 does not seem to result in significant differences in outcomes compared to those not vaccinated. Apparently there is no need to change the standards of performing spinal anesthesia in patients vaccinated with the BNT162b2 vaccine., Competing Interests: The 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., (© 2023 Elsevier Inc. All rights reserved.)
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- 2023
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12. Real-Life Data on Hydroxychloroquine or Chloroquine with or Without Azithromycin in COVID-19 Patients: A Retrospective Analysis in Brazil.
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Souza-Silva MVR, Pereira DN, Pires MC, Vasconcelos IM, Schwarzbold AV, Vasconcelos DH, Pereira EC, Manenti ERF, Costa FR, Aguiar FC, Anschau F, Bartolazzi F, Nascimento GF, Vianna HR, Batista JDL, Machado-Rugolo J, Ruschel KB, Ferreira MAP, Oliveira LS, Menezes LSM, Ziegelmann PK, Tofani MGT, Bicalho MAC, Nogueira MCA, Guimarães-Júnior MH, Aguiar RLO, Rios DRA, Polanczyk CA, and Marcolino MS
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- Aged, Female, Humans, Male, Middle Aged, Arrhythmias, Cardiac drug therapy, Azithromycin therapeutic use, Brazil epidemiology, Cohort Studies, COVID-19, Retrospective Studies, SARS-CoV-2, Chloroquine adverse effects, COVID-19 Drug Treatment, Hydroxychloroquine adverse effects
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Background: Despite no evidence showing benefits of hydroxychloroquine and chloroquine with or without azithromycin for COVID-19 treatment, these medications have been largely prescribed in Brazil., Objectives: To assess outcomes, including in-hospital mortality, electrocardiographic abnormalities, hospital length-of-stay, admission to the intensive care unit, and need for dialysis and mechanical ventilation, in hospitalized COVID-19 patients who received chloroquine or hydroxychloroquine, and to compare outcomes between those patients and their matched controls., Methods: A retrospective multicenter cohort study that included consecutive laboratory-confirmed COVID-19 patients from 37 Brazilian hospitals from March to September 2020. Propensity score was used to select matching controls by age, sex, cardiovascular comorbidities, and in-hospital use of corticosteroid. A p-value <0.05 was considered statistically significant., Results: From 7,850 COVID-19 patients, 673 (8.6%) received hydroxychloroquine and 67 (0.9%) chloroquine. The median age in the study group was 60 years (46 - 71) and 59.1% were women. During hospitalization, 3.2% of patients presented side effects and 2.2% required therapy discontinuation. Electrocardiographic abnormalities were more prevalent in the chloroquine/hydroxychloroquine group (13.2% vs. 8.2%, p=0.01), and the long corrected QT interval was the main difference (3.6% vs. 0.4%, p<0.001). The median hospital length of stay was longer in the HCQ/CQ + AZT group than in controls (9.0 [5.0, 18.0] vs. 8.0 [4.0, 14.0] days). There was no statistical differences between groups in intensive care unit admission (35.1% vs. 32.0%; p=0.282), invasive mechanical ventilation support (27.0% vs. 22.3%; p=0.074) or mortality (18.9% vs. 18.0%; p=0.682)., Conclusion: COVID-19 patients treated with chloroquine or hydroxychloroquine had a longer hospital length of stay, when compared to matched controls. Intensive care unit admission, invasive mechanical ventilation, dialysis and in-hospital mortality were similar.
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- 2023
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13. Correction: Development and validation of the MMCD score to predict kidney replacement therapy in COVID-19 patients.
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de Azevedo Figueiredo F, Ramos LEF, Silva RT, Ponce D, de Carvalho RLR, Schwarzbold AV, de Oliveira Maurílio A, Scotton ALBA, Garbini AF, Farace BL, Garcia BM, da Silva CTCA, Cimini CCR, de Carvalho CA, Dos Santos Dias C, Silveira DV, Manenti ERF, de Almeida Cenci EP, Anschau F, Aranha FG, de Aguiar FC, Bartolazzi F, Vietta GG, Nascimento GF, Noal HC, Duani H, Vianna HR, Guimarães HC, de Alvarenga JC, Chatkin JM, de Morais JDP, Machado-Rugolo J, Ruschel KB, Martins KPMP, Menezes LSM, Couto LSF, de Castro LC, Nasi LA, de Souza Cabral MA, Floriani MA, Souza MD, Souza-Silva MVR, Carneiro M, de Godoy MF, Bicalho MAC, Lima MCPB, Aliberti MJR, Nogueira MCA, Martins MFL, Guimarães-Júnior MH, da Cunha Severino Sampaio N, de Oliveira NR, Ziegelmann PK, Andrade PGS, Assaf PL, de Lima Martelli PJ, Delfino-Pereira P, Castro Martins R, Menezes RM, Francisco SC, Araújo SF, Oliveira TF, de Oliveira TC, Souza Sales TL, Avelino-Silva TJ, Ramires YC, Pires MC, and Marcolino MS
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- 2023
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14. COVID-19 outcomes in people living with HIV: Peering through the waves.
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Sales TLS, Souza-Silva MVR, Delfino-Pereira P, Neves JVB, Sacioto MF, Assis VCM, Duani H, Oliveira NR, Sampaio NDCS, Ramos LEF, Schwarzbold AV, Jorge AO, Scotton ALBA, Castro BM, Silva CTCAD, Ramos CM, Anschau F, Botoni FA, Grizende GMS, Nascimento GF, Ruschel KB, Menezes LSM, Castro LC, Nasi LA, Carneiro M, Godoy MF, Nogueira MCA, Guimarães Júnior MH, Ziegelmann PK, Almeida RC, Francisco SC, Silveira Neto ST, Araújo SF, Avelino-Silva TJ, Aliberti MJR, Pires MC, Silva ESD, and Marcolino MS
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- Female, Humans, Middle Aged, Male, SARS-CoV-2, Retrospective Studies, Intensive Care Units, COVID-19, HIV Infections complications, HIV Infections epidemiology
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Objective: To evaluate clinical characteristics and outcomes of COVID-19 patients infected with HIV, and to compare with a paired sample without HIV infection., Methods: This is a substudy of a Brazilian multicentric cohort that comprised two periods (2020 and 2021). Data was obtained through the retrospective review of medical records. Primary outcomes were admission to the intensive care unit, invasive mechanical ventilation, and death. Patients with HIV and controls were matched for age, sex, number of comorbidities, and hospital of origin using the technique of propensity score matching (up to 4:1). They were compared using the Chi-Square or Fisher's Exact tests for categorical variables and the Wilcoxon for numerical variables., Results: Throughout the study, 17,101 COVID-19 patients were hospitalized, and 130 (0.76%) of those were infected with HIV. The median age was 54 (IQR: 43.0;64.0) years in 2020 and 53 (IQR: 46.0;63.5) years in 2021, with a predominance of females in both periods. People Living with HIV (PLHIV) and their controls showed similar prevalence for admission to the ICU and invasive mechanical ventilation requirement in the two periods, with no significant differences. In 2020, in-hospital mortality was higher in the PLHIV compared to the controls (27.9% vs. 17.7%; p = 0.049), but there was no difference in mortality between groups in 2021 (25.0% vs. 25.1%; p > 0.999)., Conclusions: Our results reiterate that PLHIV were at higher risk of COVID-19 mortality in the early stages of the pandemic, however, this finding did not sustain in 2021, when the mortality rate is similar to the control group., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2023 HCFMUSP. Published by Elsevier España, S.L.U. All rights reserved.)
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- 2023
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15. Clinical characteristics and outcomes of hospital-manifested COVID-19 among Brazilians.
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Delfino-Pereira P, Pires MC, Gomes VMR, Nogueira MCA, Lima MCPB, Schwarzbold AV, Maurílio AO, Scotton ALBA, Costa ASM, Farace BL, de Castro BM, Cimini CCR, Silveira DV, Ponce D, Pereira EC, Roesch EW, Manenti ERF, Cenci EPA, Dos Santos FC, Anschau F, Aranha FG, Bartolazzi F, Nascimento GF, Vianna HR, d'Arc Lyra Batista J, de Alvarenga JC, Carvalho JDSN, Machado-Rugolo J, Ruschel KB, Menezes LSM, de Castro LC, Nasi LA, Floriani MA, Souza MD, Souza-Silva MVR, Carneiro M, Bicalho MAC, de Godoy MF, Guimarães-Júnior MH, Ziegelmann PK, Assaf PL, Martelli PJL, Finger RG, Francisco SC, Araújo SF, Oliveira TF, de Oliveira TC, Lage TM, Muller V, Ramires YC, Ferrari TCA, and Marcolino MS
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- Adult, Humans, Male, Retrospective Studies, SARS-CoV-2, Hospitalization, Comorbidity, Risk Factors, Hospitals, Hospital Mortality, COVID-19 epidemiology
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Objectives: To analyze the clinical characteristics and outcomes of admitted patients with the hospital- versus community-manifested COVID-19 and to evaluate the risk factors related to mortality in the first population., Methods: This retrospective cohort included consecutive adult patients with COVID-19, hospitalized between March and September 2020. The demographic data, clinical characteristics, and outcomes were extracted from medical records. Patients with hospital-manifested COVID-19 (study group) and those with community-manifested COVID-19 (control group) were matched by the propensity score model. Logistic regression models were used to verify the risk factors for mortality in the study group., Results: Among 7,710 hospitalized patients who had COVID-19, 7.2% developed symptoms while admitted for other reasons. Patients with hospital-manifested COVID-19 had a higher prevalence of cancer (19.2% vs 10.8%) and alcoholism (8.8% vs 2.8%) than patients with community-manifested COVID-19 and also had a higher rate of intensive care unit requirement (45.1% vs 35.2%), sepsis (23.8% vs 14.5%), and death (35.8% vs 22.5%) (P <0.05 for all). The factors independently associated with increased mortality in the study group were increasing age, male sex, number of comorbidities, and cancer., Conclusion: Hospital-manifested COVID-19 was associated with increased mortality. Increasing age, male sex, number of comorbidities, and cancer were independent predictors of mortality among those with hospital-manifested COVID-19 disease., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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16. Assessment of risk scores to predict mortality of COVID-19 patients admitted to the intensive care unit.
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Nogueira MCA, Nobre V, Pires MC, Ramos LEF, Ribeiro YCNMB, Aguiar RLO, Vigil FMB, Gomes VMR, Santos CO, Miranda DM, Durães PAA, da Costa JM, Schwarzbold AV, Gomes AGDR, Pessoa BP, Matos CC, Cimini CCR, de Carvalho CA, Ponce D, Manenti ERF, Cenci EPA, Anschau F, Costa FCC, Nascimento FJM, Bartolazzi F, Grizende GMS, Vianna HR, Nepomuceno JC, Ruschel KB, Zandoná LB, de Castro LC, Souza MD, Carneiro M, Bicalho MAC, Vilaça MDN, Bonardi NPF, de Oliveira NR, Lutkmeier R, Francisco SC, Araújo SF, Delfino-Pereira P, and Marcolino MS
- Abstract
Objectives: To assess the ABC
2 -SPH score in predicting COVID-19 in-hospital mortality, during intensive care unit (ICU) admission, and to compare its performance with other scores (SOFA, SAPS-3, NEWS2, 4C Mortality Score, SOARS, CURB-65, modified CHA2DS2-VASc, and a novel severity score)., Materials and Methods: Consecutive patients (≥ 18 years) with laboratory-confirmed COVID-19 admitted to ICUs of 25 hospitals, located in 17 Brazilian cities, from October 2020 to March 2022, were included. Overall performance of the scores was evaluated using the Brier score. ABC2 -SPH was used as the reference score, and comparisons between ABC2 -SPH and the other scores were performed by using the Bonferroni method of correction. The primary outcome was in-hospital mortality., Results: ABC2 -SPH had an area under the curve of 0.716 (95% CI 0.693-0.738), significantly higher than CURB-65, SOFA, NEWS2, SOARS, and modified CHA2DS2-VASc scores. There was no statistically significant difference between ABC2 -SPH and SAPS-3, 4C Mortality Score, and the novel severity score., Conclusion: ABC2 -SPH was superior to other risk scores, but it still did not demonstrate an excellent predictive ability for mortality in critically ill COVID-19 patients. Our results indicate the need to develop a new score, for this subset of patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Nogueira, Nobre, Pires, Ramos, Ribeiro, Aguiar, Vigil, Gomes, Santos, Miranda, Durães, Costa, Schwarzbold, Gomes, Pessoa, Matos, Cimini, Carvalho, Ponce, Manenti, Cenci, Anschau, Costa, Nascimento, Bartolazzi, Grizende, Vianna, Nepomuceno, Ruschel, Zandoná, Castro, Souza, Carneiro, Bicalho, Vilaça, Bonardi, Oliveira, Lutkmeier, Francisco, Araújo, Delfino-Pereira and Marcolino.)- Published
- 2023
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17. Potential and limitations of machine meta-learning (ensemble) methods for predicting COVID-19 mortality in a large inhospital Brazilian dataset.
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de Paiva BBM, Pereira PD, de Andrade CMV, Gomes VMR, Souza-Silva MVR, Martins KPMP, Sales TLS, de Carvalho RLR, Pires MC, Ramos LEF, Silva RT, de Freitas Martins Vieira A, Nunes AGS, de Oliveira Jorge A, de Oliveira Maurílio A, Scotton ALBA, da Silva CTCA, Cimini CCR, Ponce D, Pereira EC, Manenti ERF, Rodrigues FD, Anschau F, Botoni FA, Bartolazzi F, Grizende GMS, Noal HC, Duani H, Gomes IM, Costa JHSM, di Sabatino Santos Guimarães J, Tupinambás JT, Rugolo JM, Batista JDL, de Alvarenga JC, Chatkin JM, Ruschel KB, Zandoná LB, Pinheiro LS, Menezes LSM, de Oliveira LMC, Kopittke L, Assis LA, Marques LM, Raposo MC, Floriani MA, Bicalho MAC, Nogueira MCA, de Oliveira NR, Ziegelmann PK, Paraiso PG, de Lima Martelli PJ, Senger R, Menezes RM, Francisco SC, Araújo SF, Kurtz T, Fereguetti TO, de Oliveira TC, Ribeiro YCNMB, Ramires YC, Lima MCPB, Carneiro M, Bezerra AFB, Schwarzbold AV, de Moura Costa AS, Farace BL, Silveira DV, de Almeida Cenci EP, Lucas FB, Aranha FG, Bastos GAN, Vietta GG, Nascimento GF, Vianna HR, Guimarães HC, de Morais JDP, Moreira LB, de Oliveira LS, de Deus Sousa L, de Souza Viana L, de Souza Cabral MA, Ferreira MAP, de Godoy MF, de Figueiredo MP, Guimarães-Junior MH, de Paula de Sordi MA, da Cunha Severino Sampaio N, Assaf PL, Lutkmeier R, Valacio RA, Finger RG, de Freitas R, Guimarães SMM, Oliveira TF, Diniz THO, Gonçalves MA, and Marcolino MS
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- Adult, Humans, Female, Middle Aged, Male, Brazil, Hospitals, Hospitalization, Machine Learning, COVID-19
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The majority of early prediction scores and methods to predict COVID-19 mortality are bound by methodological flaws and technological limitations (e.g., the use of a single prediction model). Our aim is to provide a thorough comparative study that tackles those methodological issues, considering multiple techniques to build mortality prediction models, including modern machine learning (neural) algorithms and traditional statistical techniques, as well as meta-learning (ensemble) approaches. This study used a dataset from a multicenter cohort of 10,897 adult Brazilian COVID-19 patients, admitted from March/2020 to November/2021, including patients [median age 60 (interquartile range 48-71), 46% women]. We also proposed new original population-based meta-features that have not been devised in the literature. Stacking has shown to achieve the best results reported in the literature for the death prediction task, improving over previous state-of-the-art by more than 46% in Recall for predicting death, with AUROC 0.826 and MacroF1 of 65.4%. The newly proposed meta-features were highly discriminative of death, but fell short in producing large improvements in final prediction performance, demonstrating that we are possibly on the limits of the prediction capabilities that can be achieved with the current set of ML techniques and (meta-)features. Finally, we investigated how the trained models perform on different hospitals, showing that there are indeed large differences in classifier performance between different hospitals, further making the case that errors are produced by factors that cannot be modeled with the current predictors., (© 2023. The Author(s).)
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- 2023
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18. Myocardial Injury and Prognosis in Hospitalized COVID-19 Patients in Brazil: Results From The Brazilian COVID-19 Registry.
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Barbosa HC, Martins MAP, Jesus JC, Meira KC, Passaglia LG, Sacioto MF, Bezerra AFB, Schwarzbold AV, Maurílio AO, Farace BL, Silva CTCAD, Cimini CCR, Silveira DV, Carazai DDR, Ponce D, Costa EVA, Manenti ERF, Cenci EPA, Bartolazzi F, Madeira GCC, Nascimento GF, Velloso IVP, Batista JDL, Morais JDP, Carvalho JDSN, Ruschel KB, Martins KPMP, Zandoná LB, Menezes LSM, Kopittke L, Castro LC, Nasi LA, Floriani MA, Souza MD, Carneiro M, Bicalho MAC, Lima MCPB, Godoy MF, Guimarães-Júnior MH, Mendes PM, Delfino-Pereira P, Ribeiro RJE, Finger RG, Menezes RM, Francisco SC, Araújo SF, Oliveira TF, Oliveira TC, Polanczyk CA, and Marcolino MS
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- Female, Humans, Male, Middle Aged, Brazil epidemiology, C-Reactive Protein, Cohort Studies, Prognosis, Aged, COVID-19, Heart Injuries
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Background: Cardiovascular complications of COVID-19 are important aspects of the disease's pathogenesis and prognosis. Evidence on the prognostic role of troponin and myocardial injury in Latin American hospitalized COVID-19 patients is still scarce., Objectives: To evaluate myocardial injury as independent predictor of in-hospital mortality and invasive mechanical ventilation support in hospitalized patients, from the Brazilian COVID-19 Registry., Methods: This cohort study is a substudy of the Brazilian COVID-19 Registry, conducted in 31 Brazilian hospitals of 17 cities, March-September 2020. Primary outcomes included in-hospital mortality and invasive mechanical ventilation support. Models for the primary outcomes were estimated by Poisson regression with robust variance, with statistical significance of p<0.05., Results: Of 2,925 patients (median age of 60 years [48-71], 57.1% men), 27.3% presented myocardial injury. The proportion of patients with comorbidities was higher among patients with cardiac injury (median 2 [1-2] vs. 1 [0-2]). Patients with myocardial injury had higher median levels of brain natriuretic peptide, lactate dehydrogenase, creatine phosphokinase, N-terminal pro-brain natriuretic peptide, and C-reactive protein than patients without myocardial injury. As independent predictors, C-reactive protein and platelet counts were related to the risk of death, and neutrophils and platelet counts were related to the risk of invasive mechanical ventilation support. Patients with high troponin levels presented a higher risk of death (RR 2.03, 95% CI 1.60-2.58) and invasive mechanical ventilation support (RR 1.87, 95% CI 1.57-2.23), when compared to those with normal troponin levels., Conclusion: Cardiac injury was an independent predictor of in-hospital mortality and the need for invasive mechanical ventilation support in hospitalized COVID-19 patients.
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- 2023
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19. Incipient Parallel Evolution of SARS-CoV-2 Deltacron Variant in South Brazil.
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Sant'Anna FH, Finger Andreis T, Salvato RS, Muterle Varela AP, Comerlato J, Gregianini TS, Barcellos RB, de Souza Godinho FM, Resende PC, da Luz Wallau G, Y Castro TR, Casarin BC, de Almeida Vieira A, Schwarzbold AV, de Arruda Trindade P, Tumioto Giannini GL, Freese L, Bristot G, Brasil CS, de Oliveira Rocha B, Martins PB, de Oliveira FH, van Oosterhout C, and Wendland E
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With the coexistence of multiple lineages and increased international travel, recombination and gene flow are likely to become increasingly important in the adaptive evolution of SARS-CoV-2. These processes could result in genetic introgression and the incipient parallel evolution of multiple recombinant lineages. However, identifying recombinant lineages is challenging, and the true extent of recombinant evolution in SARS-CoV-2 may be underestimated. This study describes the first SARS-CoV-2 Deltacron recombinant case identified in Brazil. We demonstrate that the recombination breakpoint is at the beginning of the Spike gene. The 5' genome portion (circa 22 kb) resembles the AY.101 (Delta), and the 3' genome portion (circa 8 kb nucleotides) is most similar to the BA.1.1 (Omicron). Furthermore, evolutionary genomic analyses indicate that the new strain emerged after a single recombination event between lineages of diverse geographical locations in December 2021 in South Brazil. This Deltacron, AYBA-RS, is one of the dozens of recombinants described in 2022. The submission of only four sequences in the GISAID database suggests that this lineage had a minor epidemiological impact. However, the recent emergence of this and other Deltacron recombinant lineages (XD, XF, and XS) suggests that gene flow and recombination may play an increasingly important role in the COVID-19 pandemic. We explain the evolutionary and population genetic theory that supports this assertion, concluding that this stresses the need for continued genomic surveillance. This monitoring is vital for countries where multiple variants are present, as well as for countries that receive significant inbound international travel.
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- 2023
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20. The "Histoplasmosis Porto Alegre manifesto"-Addressing disseminated histoplasmosis in AIDS.
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Pasqualotto AC, Queiroz-Telles F, Chebabo A, Leitao TMJS, Falci DR, Xavier MO, Bay MB, Sprinz E, Dalla Lana D, Vincentini AP, Damasceno LS, Schwarzbold AV, Ferreira PA, Godoy CM, Vidal JE, Basso R, Driemeyer C, Aquino VR, Severo CB, Ferreira MS, Bastos C, Prohaska F, Melo M, Cavassin FB, Lacerda M, Soares R, Zancope-Oliveira R, Teixeira M, Perez F, Caceres DH, Rodriguez-Tudela JL, Chiller T, and Colombo AL
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- Humans, Histoplasmosis diagnosis, Acquired Immunodeficiency Syndrome complications, AIDS-Related Opportunistic Infections drug therapy
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Competing Interests: The authors have declared that no competing interests exist.
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- 2023
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21. Frequency and burden of neurological manifestations upon hospital presentation in COVID-19 patients: Findings from a large Brazilian cohort.
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Marcolino MS, Anschau F, Kopittke L, Pires MC, Barbosa IG, Pereira DN, Ramos LEF, Assunção LFI, Costa ASM, Nogueira MCA, Duani H, Martins KPMP, Moreira LB, Silva CTCAD, Oliveira NR, Ziegelmann PK, Guimarães-Júnior MH, Lima MOSS, Aguiar RLO, Menezes LSM, Oliveira TF, Souza MD, Farace BL, Cimini CCR, Maurílio AO, Guimarães SMM, Araújo SF, Nascimento GF, Silveira DV, Ruschel KB, Oliveira TC, Schwarzbold AV, Nasi LA, Floriani MA, Santos VBD, Ramos CM, Alvarenga JC, Scotton ALBA, Manenti ERF, Crestani GP, Batista JDL, Ponce D, Machado-Rugolo J, Bezerra AFB, Martelli PJL, Vianna HR, Castro LC, Medeiros CRG, Vietta GG, Pereira EC, Chatkin JM, Godoy MF, Delfino-Pereira P, and Teixeira AL
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- Humans, SARS-CoV-2, Anosmia, Brazil epidemiology, Headache epidemiology, Headache etiology, Hospitals, COVID-19 complications, COVID-19 epidemiology, Ageusia epidemiology, Ageusia etiology, Shock, Septic complications
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Background: Scientific data regarding the prevalence of COVID-19 neurological manifestations and prognosis in Latin America countries is still lacking. Therefore, the study aims to understand neurological manifestations of SARS-CoV 2 infection and outcomes in the Brazilian population., Methods: This study is part of the Brazilian COVID-19 Registry, a multicentric cohort, including data from 37 hospitals. For the present analysis, patients were grouped according to the presence of reported symptoms (i.e., headache; anosmia and ageusia; syncope and dizziness) vs. clinically-diagnosed neurological manifestations (clinically-defined neurological syndrome: neurological signs or diagnoses captured by clinical evaluation) and matched with patients without neurological manifestations by age, sex, number of comorbidities, hospital of admission, and whether or not patients had underlying neurological disease., Results: From 6,635 hospitalized patients with COVID-19, 30.8% presented reported neurological manifestations, 10.3% were diagnosed with a neurological syndrome and 60.1% did not show any neurological manifestations. In patients with reported symptoms, the most common ones were headache (20.7%), ageusia (11.1%) and anosmia (8.0%). In patients with neurological syndromes, acute encephalopathy was the most common diagnosis (9.7%). In the matched analysis, patients with neurological syndromes presented more cases of septic shock (17.0 vs. 13.0%, p = 0.045), intensive care unit admission (45.3 vs. 38.9%, p = 0.023), and mortality (38.7 vs. 32.6%, p = 0.026; and 39.2 vs. 30.3%, p < 0.001) when compared to controls., Conclusion: COVID-19 in-hospital patients with clinically defined neurological syndromes presented a higher incidence of septic shock, ICU admission and death when compared to controls., Competing Interests: Declaration of Competing Interest The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2022. Published by Elsevier B.V.)
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- 2022
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22. Hospital characteristics associated with COVID-19 mortality: data from the multicenter cohort Brazilian Registry.
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Souza-Silva MVR, Ziegelmann PK, Nobre V, Gomes VMR, Etges APBDS, Schwarzbold AV, Nunes AGS, Maurílio AO, Scotton ALBA, Costa ASM, Glaeser AB, Farace BL, Ribeiro BN, Ramos CM, Cimini CCR, de Carvalho CA, Rempel C, Silveira DV, Carazai DDR, Ponce D, Pereira EC, Kroger EMS, Manenti ERF, Cenci EPA, Lucas FB, Dos Santos FC, Anschau F, Botoni FA, Aranha FG, de Aguiar FC, Bartolazzi F, Crestani GP, Vietta GG, Nascimento GF, Noal HC, Duani H, Vianna HR, Guimarães HC, de Alvarenga JC, Chatkin JM, de Morais JDP, Carvalho JDSN, Rugolo JM, Ruschel KB, Gomes LBW, de Oliveira LS, Zandoná LB, Pinheiro LS, Pacheco LS, Menezes LDSM, Sousa LD, de Moura LCS, Santos LEA, Nasi LA, Cabral MAS, Floriani MA, Souza MD, Carneiro M, de Godoy MF, Cardoso MMA, Nogueira MCA, Lima MOSS, de Figueiredo MP, Guimarães-Júnior MH, Sampaio NDCS, de Oliveira NR, Andrade PGS, Assaf PL, Martelli PJL, Martins RC, Valacio RA, Pozza R, Menezes RM, Mourato RLS, de Abreu RM, Silva RF, Francisco SC, Guimarães SMM, Araújo SF, Oliveira TF, Kurtz T, Fereguetti TO, de Oliveira TC, Ribeiro YCNMB, Ramires YC, Polanczyk CA, and Marcolino MS
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- Humans, Adolescent, Pandemics, Brazil epidemiology, Retrospective Studies, Intensive Care Units, Hospital Mortality, Cohort Studies, Hospitals, General, Registries, COVID-19
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The COVID-19 pandemic caused unprecedented pressure over health care systems worldwide. Hospital-level data that may influence the prognosis in COVID-19 patients still needs to be better investigated. Therefore, this study analyzed regional socioeconomic, hospital, and intensive care units (ICU) characteristics associated with in-hospital mortality in COVID-19 patients admitted to Brazilian institutions. This multicenter retrospective cohort study is part of the Brazilian COVID-19 Registry. We enrolled patients ≥ 18 years old with laboratory-confirmed COVID-19 admitted to the participating hospitals from March to September 2020. Patients' data were obtained through hospital records. Hospitals' data were collected through forms filled in loco and through open national databases. Generalized linear mixed models with logit link function were used for pooling mortality and to assess the association between hospital characteristics and mortality estimates. We built two models, one tested general hospital characteristics while the other tested ICU characteristics. All analyses were adjusted for the proportion of high-risk patients at admission. Thirty-one hospitals were included. The mean number of beds was 320.4 ± 186.6. These hospitals had eligible 6556 COVID-19 admissions during the study period. Estimated in-hospital mortality ranged from 9.0 to 48.0%. The first model included all 31 hospitals and showed that a private source of funding (β = - 0.37; 95% CI - 0.71 to - 0.04; p = 0.029) and location in areas with a high gross domestic product (GDP) per capita (β = - 0.40; 95% CI - 0.72 to - 0.08; p = 0.014) were independently associated with a lower mortality. The second model included 23 hospitals and showed that hospitals with an ICU work shift composed of more than 50% of intensivists (β = - 0.59; 95% CI - 0.98 to - 0.20; p = 0.003) had lower mortality while hospitals with a higher proportion of less experienced medical professionals had higher mortality (β = 0.40; 95% CI 0.11-0.68; p = 0.006). The impact of those association increased according to the proportion of high-risk patients at admission. In-hospital mortality varied significantly among Brazilian hospitals. Private-funded hospitals and those located in municipalities with a high GDP had a lower mortality. When analyzing ICU-specific characteristics, hospitals with more experienced ICU teams had a reduced mortality., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)
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- 2022
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23. Predictors of venous thromboembolism in COVID-19 patients: results of the COVID-19 Brazilian Registry.
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da Silveira WC, Ramos LEF, Silva RT, de Paiva BBM, Pereira PD, Schwarzbold AV, Garbini AF, Barreira BSM, de Castro BM, Ramos CM, Gomes CD, Cimini CCR, Pereira EC, Roesch EW, Kroger EMS, Aranha FFMG, Anschau F, Botoni FA, Aranha FG, Crestani GP, Vietta GG, Bastos GAN, Costa JHSM, da Fonseca JRCS, Ruschel KB, de Oliveira LS, Pinheiro LS, Pacheco LS, Segala LB, Couto LSF, Kopittke L, Floriani MA, Silva MM, Carneiro M, Ferreira MAP, Martins MAP, de Faria MNZ, Nogueira MCA, Guimarães Júnior MH, Sampaio NDCS, de Oliveira NR, Pertile NM, Andrade PGS, Assaf PL, Valacio RA, Menezes RM, Francisco SC, Guimarães SMM, Araújo SF, Rezende SM, Pereira SA, Kurtz T, Fereguetti TO, Polanczyk CA, Pires MC, Gonçalves MA, and Marcolino MS
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- Adult, Anticoagulants, Brazil epidemiology, C-Reactive Protein, Cohort Studies, Female, Humans, Lactates, Male, Oxygen, Registries, Risk Factors, COVID-19 complications, COVID-19 epidemiology, Venous Thromboembolism epidemiology, Venous Thromboembolism etiology, Venous Thromboembolism prevention & control
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Previous studies that assessed risk factors for venous thromboembolism (VTE) in COVID-19 patients have shown inconsistent results. Our aim was to investigate VTE predictors by both logistic regression (LR) and machine learning (ML) approaches, due to their potential complementarity. This cohort study of a large Brazilian COVID-19 Registry included 4120 COVID-19 adult patients from 16 hospitals. Symptomatic VTE was confirmed by objective imaging. LR analysis, tree-based boosting, and bagging were used to investigate the association of variables upon hospital presentation with VTE. Among 4,120 patients (55.5% men, 39.3% critical patients), VTE was confirmed in 6.7%. In multivariate LR analysis, obesity (OR 1.50, 95% CI 1.11-2.02); being an ex-smoker (OR 1.44, 95% CI 1.03-2.01); surgery ≤ 90 days (OR 2.20, 95% CI 1.14-4.23); axillary temperature (OR 1.41, 95% CI 1.22-1.63); D-dimer ≥ 4 times above the upper limit of reference value (OR 2.16, 95% CI 1.26-3.67), lactate (OR 1.10, 95% CI 1.02-1.19), C-reactive protein levels (CRP, OR 1.09, 95% CI 1.01-1.18); and neutrophil count (OR 1.04, 95% CI 1.005-1.075) were independent predictors of VTE. Atrial fibrillation, peripheral oxygen saturation/inspired oxygen fraction (SF) ratio and prophylactic use of anticoagulants were protective. Temperature at admission, SF ratio, neutrophil count, D-dimer, CRP and lactate levels were also identified as predictors by ML methods. By using ML and LR analyses, we showed that D-dimer, axillary temperature, neutrophil count, CRP and lactate levels are risk factors for VTE in COVID-19 patients., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)
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- 2022
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24. Development and validation of the MMCD score to predict kidney replacement therapy in COVID-19 patients.
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Figueiredo FA, Ramos LEF, Silva RT, Ponce D, de Carvalho RLR, Schwarzbold AV, Maurílio AO, Scotton ALBA, Garbini AF, Farace BL, Garcia BM, da Silva CTCA, Cimini CCR, de Carvalho CA, Dias CDS, Silveira DV, Manenti ERF, Cenci EPA, Anschau F, Aranha FG, de Aguiar FC, Bartolazzi F, Vietta GG, Nascimento GF, Noal HC, Duani H, Vianna HR, Guimarães HC, de Alvarenga JC, Chatkin JM, de Morais JDP, Machado-Rugolo J, Ruschel KB, Martins KPMP, Menezes LSM, Couto LSF, de Castro LC, Nasi LA, Cabral MAS, Floriani MA, Souza MD, Souza-Silva MVR, Carneiro M, de Godoy MF, Bicalho MAC, Lima MCPB, Aliberti MJR, Nogueira MCA, Martins MFL, Guimarães-Júnior MH, Sampaio NDCS, de Oliveira NR, Ziegelmann PK, Andrade PGS, Assaf PL, Martelli PJL, Delfino-Pereira P, Martins RC, Menezes RM, Francisco SC, Araújo SF, Oliveira TF, de Oliveira TC, Sales TLS, Avelino-Silva TJ, Ramires YC, Pires MC, and Marcolino MS
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- Adult, Aged, Dextrans, Female, Humans, Male, Middle Aged, Mitomycin, ROC Curve, Renal Replacement Therapy adverse effects, Retrospective Studies, Risk Factors, Acute Kidney Injury diagnosis, Acute Kidney Injury epidemiology, Acute Kidney Injury therapy, COVID-19 therapy
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Background: Acute kidney injury (AKI) is frequently associated with COVID-19, and the need for kidney replacement therapy (KRT) is considered an indicator of disease severity. This study aimed to develop a prognostic score for predicting the need for KRT in hospitalised COVID-19 patients, and to assess the incidence of AKI and KRT requirement., Methods: This study is part of a multicentre cohort, the Brazilian COVID-19 Registry. A total of 5212 adult COVID-19 patients were included between March/2020 and September/2020. Variable selection was performed using generalised additive models (GAM), and least absolute shrinkage and selection operator (LASSO) regression was used for score derivation. Accuracy was assessed using the area under the receiver operating characteristic curve (AUC-ROC)., Results: The median age of the model-derivation cohort was 59 (IQR 47-70) years, 54.5% were men, 34.3% required ICU admission, 20.9% evolved with AKI, 9.3% required KRT, and 15.1% died during hospitalisation. The temporal validation cohort had similar age, sex, ICU admission, AKI, required KRT distribution and in-hospital mortality. The geographic validation cohort had similar age and sex; however, this cohort had higher rates of ICU admission, AKI, need for KRT and in-hospital mortality. Four predictors of the need for KRT were identified using GAM: need for mechanical ventilation, male sex, higher creatinine at hospital presentation and diabetes. The MMCD score had excellent discrimination in derivation (AUROC 0.929, 95% CI 0.918-0.939) and validation (temporal AUROC 0.927, 95% CI 0.911-0.941; geographic AUROC 0.819, 95% CI 0.792-0.845) cohorts and good overall performance (Brier score: 0.057, 0.056 and 0.122, respectively). The score is implemented in a freely available online risk calculator ( https://www.mmcdscore.com/ )., Conclusions: The use of the MMCD score to predict the need for KRT may assist healthcare workers in identifying hospitalised COVID-19 patients who may require more intensive monitoring, and can be useful for resource allocation., (© 2022. The Author(s).)
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- 2022
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25. Neurological manifestations by sex and age group in COVID-19 inhospital patients.
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Pereira DN, Bicalho MAC, Jorge AO, Gomes AGDR, Schwarzbold AV, Araújo ALH, Cimini CCR, Ponce D, Rios DRA, Grizende GMS, Manenti ERF, Anschau F, Aranha FG, Bartolazzi F, Batista JDL, Tupinambás JT, Ruschel KB, Ferreira MAP, Paraíso PG, Araújo SF, Teixeira AL, and Marcolino MS
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Introduction: Neurological manifestations have been associated with a poorer prognosis in COVID-19. However, data regarding their incidence according to sex and age groups is still lacking., Methods: This retrospective multicentric cohort collected data from 39 Brazilian hospitals from 17 cities, from adult COVID-19 admitted from March 2020 to January 2022. Neurological manifestations presented at hospital admission were assessed according to incidence by sex and age group., Results: From 13,603 COVID-19 patients, median age was 60 years old and 53.0% were men. Women were more likely to present with headaches (22.4% vs. 17.7%, p < 0.001; OR 1.36, 95% confidence interval [CI] 1.22-1.52) than men and also presented a lower risk of having seizures (OR 0.43, 95% CI 0.20-0.94). Although delirium was more frequent in women (6.6% vs. 5.7%, p = 0.020), sex was not associated with delirium in the multivariable logistc regresssion analysis. Delirium, syncope and coma increased with age (1.5% [18-39 years] vs. 22.4% [80 years or over], p < 0.001, OR 1.07, 95% CI 1.06-1.07; 0.7% vs. 1.7%, p = 0.002, OR 1.01, 95% CI 1.00-1.02; 0.2% vs. 1.3% p < 0.001, OR 1.04, 95% CI 1.02-1.06), while, headache (26.5% vs. 7.1%, OR 0.98, 95% CI 0.98-0.99), anosmia (11.4% vs. 3.3%, OR 0.99, 95% CI] 0.98-0.99 and ageusia (13.1% vs. 3.5%, OR 0.99, CI 0.98-0.99) decreased (p < 0.001 for all)., Conclusion: Older COVID-19 patients were more likely to present delirium, syncope and coma, while the incidence of anosmia, ageusia and headaches decreased with age. Women were more likely to present headache, and less likely to present seizures., (© 2022 The Authors.)
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- 2022
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26. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE - Coalition V): A double-blind, multicentre, randomised, controlled trial.
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Avezum Á, Oliveira GBF, Oliveira H, Lucchetta RC, Pereira VFA, Dabarian AL, D O Vieira R, Silva DV, Kormann APM, Tognon AP, De Gasperi R, Hernandes ME, Feitosa ADM, Piscopo A, Souza AS, Miguel CH, Nogueira VO, Minelli C, Magalhães CC, Morejon KML, Bicudo LS, Souza GEC, Gomes MAM, Fo JJFR, Schwarzbold AV, Zilli A, Amazonas RB, Moreira FR, Alves LBO, Assis SRL, Neves PDMM, Matuoka JY, Boszczowski I, Catarino DGM, Veiga VC, Azevedo LCP, Rosa RG, Lopes RD, Cavalcanti AB, and Berwanger O
- Abstract
Background: 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., Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540., Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04])., Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting., Funding: COALITION COVID-19 Brazil and EMS., Competing Interests: AA reports consultant and lectures fees from Bayer, NovoNordisk and Lilly outside of this submitted work, and research grants from Bayer, EMS Pharma and Population Health Research Institute. GBFO received honoraria for lectures from Novartis and Janssen outside of this submitted work; AD reports lecture fees from Bayer, Libbs, Apsen, and Biolab outside of this submitted work. ASS reports lectures fees from BioLab, Torrents and Servier. AVS reported research grants from AstraZeneca, MSD, Esperion, Clover Biopharm e Enanta Pharmaceutical outside of this submitted work. ABC received honoraria for lectures from EMS Pharma. LCPA reports personal fees from Baxter, Pfizer, and Halex-Istar; and grants from Ache Laboratorios Farmaceuticos, outside of this submitted work. OB reports grants from AstraZeneca, Pfizer, Bayer, Boehringer Ingelheim, Servier, and Amgen, and advisory board and personal fees from Novartis, outside of this submitted work. RBA reports to be an EMS employee. RDL reports grants and personal fees from Bristol Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi; and personal fees from Amgen, Bayer, and Boehringer Ingelheim, outside of this submitted work. RCR received honoraria for lectures from Novartis outside of this submitted work; VCV reports grants from Aspen Pharma, Pfizer, and Cristalia, outside of this submitted work. The other authors have no conflict to declare., (© 2022 The Authors.)
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- 2022
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27. In-hospital mortality and severe outcomes after hospital discharge due to COVID-19: A prospective multicenter study from Brazil.
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Perazzo H, Cardoso SW, Ribeiro MPD, Moreira R, Coelho LE, Jalil EM, Japiassú AM, Gouvêa EP, Nunes EP, Andrade HB, Gouvêa LB, Ferreira MT, Rodrigues PMA, Moreira R, Geraldo K, Freitas L, Pacheco VV, João EC, Fuller T, Rocha VD, Nunes CLX, Souza TNL, Toscano ALCC, Schwarzbold AV, Noal HC, Pinto GA, Lemos PMO, Santos C, Mello FCQ, Veloso VG, and Grinsztejn B
- Abstract
Background: We evaluated in-hospital mortality and outcomes incidence after hospital discharge due to COVID-19 in a Brazilian multicenter cohort., Methods: This prospective multicenter study (RECOVER-SUS, NCT04807699) included COVID-19 patients hospitalized in public tertiary hospitals in Brazil from June 2020 to March 2021. Clinical assessment and blood samples were performed at hospital admission, with post-hospital discharge remote visits. Hospitalized participants were followed-up until March 31, 2021. The outcomes were in-hospital mortality and incidence of rehospitalization or death after hospital discharge. Kaplan-Meier curves and Cox proportional-hazard models were performed., Findings: 1589 participants [54.5% male, age=62 (IQR 50-70) years; BMI=28.4 (IQR,24.9-32.9) Kg/m² and 51.9% with diabetes] were included. A total of 429 individuals [27.0% (95%CI,24.8-29.2)] died during hospitalization (median time 14 (IQR,9-24) days). Older age [vs<40 years; age=60-69 years-aHR=1.89 (95%CI,1.08-3.32); age=70-79 years-aHR=2.52 (95%CI,1.42-4.45); age≥80-aHR=2.90 (95%CI 1.54-5.47)]; noninvasive or mechanical ventilation at admission [vs facial-mask or none; aHR=1.69 (95%CI 1.30-2.19)]; SAPS-III score≥57 [vs<57; aHR=1.47 (95%CI 1.13-1.92)] and SOFA score≥10 [vs <10; aHR=1.51 (95%CI 1.08-2.10)] were independently associated with in-hospital mortality. A total of 65 individuals [6.7% (95%CI 5.3-8.4)] had a rehospitalization or death [rate=323 (95%CI 250-417) per 1000 person-years] in a median time of 52 (range 1-280) days post-hospital discharge. Age ≥ 60 years [vs <60, aHR=2.13 (95%CI 1.15-3.94)] and SAPS-III ≥57 at admission [vs <57, aHR=2.37 (95%CI 1.22-4.59)] were independently associated with rehospitalization or death after hospital discharge., Interpretation: High in-hospital mortality rates due to COVID-19 were observed and elderly people remained at high risk of rehospitalization and death after hospital discharge., Funding: Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and Programa INOVA-FIOCRUZ., Competing Interests: Estevão Portela Nunes has received payment for lectures by Gilead; Alexandre Vargas Schwarzbold has received grants from AZ, MSD and Clover Biopharm; Fernanda Carvalho de Queiroz Mello has been acting as the President of the Society of Pneumonology and Tisiology fo the State of Rio de Janeiro (no payment) and Beatriz Grinsztejn has been participating in Advisory Board of Merck; GSK/ViiV and Janssen; The other authors declare no conflicts of interest., (© 2022 The Author(s).)
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- 2022
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28. Hypothyroidism does not lead to worse prognosis in COVID-19: findings from the Brazilian COVID-19 registry.
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Pereira DN, Silveira LFG, Guimarães MMM, Polanczyk CA, Nunes AGS, Costa ASM, Farace BL, Cimini CCR, Carvalho CA, Ponce D, Roesch EW, Manenti ERF, Lucas FB, Rodrigues FD, Anschau F, Aranha FG, Bartolazzi F, Vietta GG, Nascimento GF, Duani H, Vianna HR, Guimarães HC, Costa JHSM, Batista JDL, Alvarenga JC, Chatkin JM, Morais JDP, Machado-Rugolo J, Ruschel KB, Pinheiro LS, Menezes LSM, Couto LSF, Kopittke L, Castro LC, Nasi LA, Cabral MAS, Floriani MA, Souza MD, Carneiro M, Bicalho MAC, Godoy MF, Nogueira MCA, Guimarães Júnior MH, Sampaio NDCS, Oliveira NR, Assaf PL, Finger RG, Campos RX, Menezes RM, Francisco SC, Alvarenga SP, Guimarães SMM, Araújo SF, Oliveira TF, Diniz THO, Ramires YC, Cenci EPA, Oliveira TC, Schwarzbold AV, Ziegelmann PK, Pozza R, Carvalho CS, Pires MC, and Marcolino MS
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- Aged, COVID-19 Testing, Female, Hospital Mortality, Humans, Prognosis, Registries, SARS-CoV-2, COVID-19, Hypothyroidism complications, Hypothyroidism epidemiology
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Background: It is not clear whether previous thyroid diseases influence the course and outcomes of COVID-19., Methods: The study is a part of a multicentric cohort of patients with confirmed COVID-19 diagnosis from 37 hospitals. Matching for age, sex, number of comorbidities, and hospital was performed for the paired analysis., Results: Of 7,762 patients with COVID-19, 526 had previously diagnosed hypothyroidism and 526 were matched controls. The median age was 70 years, and 68.3% were females. The prevalence of comorbidities was similar, except for coronary and chronic kidney diseases that were higher in the hypothyroidism group (p=0.015 and p=0.001). D-dimer levels were lower in patients with hypothyroid (p=0.037). In-hospital management was similar, but hospital length-of-stay (p=0.029) and mechanical ventilation requirement (p=0.006) were lower for patients with hypothyroidism. There was a trend of lower in-hospital mortality in patients with hypothyroidism (22.1% vs 27.0%; p=0.062)., Conclusion: Patients with hypothyroidism had a lower requirement of mechanical ventilation and showed a trend of lower in-hospital mortality. Therefore, hypothyroidism does not seem to be associated with a worse prognosis., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2022
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29. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial.
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Bravo L, Smolenov I, Han HH, Li P, Hosain R, Rockhold F, Clemens SAC, Roa C Jr, Borja-Tabora C, Quinsaat A, Lopez P, López-Medina E, Brochado L, Hernández EA, Reynales H, Medina T, Velasquez H, Toloza LB, Rodriguez EJ, de Salazar DIM, Rodríguez CA, Sprinz E, Cerbino-Neto J, Luz KG, Schwarzbold AV, Paiva MS, Carlos J, Montellano MEB, de Los Reyes MRA, Yu CY, Alberto ER, Panaligan MM, Salvani-Bautista M, Buntinx E, Hites M, Martinot JB, Bhorat QE, Badat A, Baccarini C, Hu B, Jurgens J, Engelbrecht J, Ambrosino D, Richmond P, Siber G, Liang J, and Clemens R
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- Adolescent, Adult, Aged, Alum Compounds therapeutic use, Belgium, Brazil, Colombia, Double-Blind Method, Female, Humans, Male, Middle Aged, Oligodeoxyribonucleotides therapeutic use, Philippines, Protein Multimerization, Recombinant Proteins therapeutic use, Risk, SARS-CoV-2, South Africa, Vaccine Efficacy, Young Adult, Adjuvants, Immunologic therapeutic use, COVID-19 prevention & control, COVID-19 Vaccines therapeutic use, Spike Glycoprotein, Coronavirus therapeutic use
- Abstract
Background: A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019., Methods: This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 μg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020-004272-17) and ClinicalTrials.gov (NCT04672395)., Findings: 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8), 83·7% (97·86% CI 55·9-95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3-100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3-90·4) for delta, 91·8% (44·9-99·8) for gamma, and 58·6% (13·3-81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63-103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups., Interpretation: Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant., Funding: Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations., Competing Interests: Declaration of interests IS, HHH, PLi, RH, CB, BH, and JL are full-time employees of Clover Biopharmaceuticals. FR is a statistical adviser for Clover Biopharmaceuticals. RC, DA, PR, and GS are scientific advisers for Clover Biopharmaceuticals. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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- 2022
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30. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 lineages circulating in Brazil.
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Clemens SAC, Folegatti PM, Emary KRW, Weckx LY, Ratcliff J, Bibi S, De Almeida Mendes AV, Milan EP, Pittella A, Schwarzbold AV, Sprinz E, Aley PK, Bonsall D, Fraser C, Fuskova M, Gilbert SC, Jenkin D, Kelly S, Kerridge S, Lambe T, Marchevsky NG, Mujadidi YF, Plested E, Ramasamy MN, Simmonds P, Golubchik T, Voysey M, and Pollard AJ
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- Adolescent, Adult, Aged, Brazil, ChAdOx1 nCoV-19, Cohort Studies, Dose-Response Relationship, Immunologic, Female, Hospitalization, Humans, Male, Middle Aged, Treatment Outcome, Vaccination, Viral Load immunology, Young Adult, COVID-19 immunology, COVID-19 virology, COVID-19 Vaccines immunology, Phylogeny, SARS-CoV-2 immunology
- Abstract
Several COVID-19 vaccines have shown good efficacy in clinical trials, but there remains uncertainty about the efficacy of vaccines against different variants. Here, we investigate the efficacy of ChAdOx1 nCoV-19 (AZD1222) against symptomatic COVID-19 in a post-hoc exploratory analysis of a Phase 3 randomised trial in Brazil (trial registration ISRCTN89951424). Nose and throat swabs were tested by PCR in symptomatic participants. Sequencing and genotyping of swabs were performed to determine the lineages of SARS-CoV-2 circulating during the study. Protection against any symptomatic COVID-19 caused by the Zeta (P.2) variant was assessed in 153 cases with vaccine efficacy (VE) of 69% (95% CI 55, 78). 49 cases of B.1.1.28 occurred and VE was 73% (46, 86). The Gamma (P.1) variant arose later in the trial and fewer cases (N = 18) were available for analysis. VE was 64% (-2, 87). ChAdOx1 nCoV-19 provided 95% protection (95% CI 61%, 99%) against hospitalisation due to COVID-19. In summary, we report that ChAdOx1 nCoV-19 protects against emerging variants in Brazil despite the presence of the spike protein mutation E484K., (© 2021. The Author(s).)
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- 2021
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31. ABC 2 -SPH risk score for in-hospital mortality in COVID-19 patients: development, external validation and comparison with other available scores.
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Marcolino MS, Pires MC, Ramos LEF, Silva RT, Oliveira LM, Carvalho RLR, Mourato RLS, Sánchez-Montalvá A, Raventós B, Anschau F, Chatkin JM, Nogueira MCA, Guimarães-Júnior MH, Vietta GG, Duani H, Ponce D, Ziegelmann PK, Castro LC, Ruschel KB, Cimini CCR, Francisco SC, Floriani MA, Nascimento GF, Farace BL, Monteiro LS, Souza-Silva MVR, Sales TLS, Martins KPMP, Borges do Nascimento IJ, Fereguetti TO, Ferrara DTMO, Botoni FA, Etges APBS, Schwarzbold AV, Maurílio AO, Scotton ALBA, Weber AP, Costa ASM, Glaeser AB, Madureira AAC, Bhering AR, de Castro BM, da Silva CTCA, Ramos CM, Gomes CD, de Carvalho CA, Silveira DV, Cezar E, Pereira EC, Kroger EMS, Vallt FB, Lucas FB, Aranha FG, Bartolazzi F, Crestani GP, Bastos GAN, Madeira GCC, Noal HC, Vianna HR, Guimarães HC, Gomes IM, Molina I, Batista JDL, de Alvarenga JC, Guimarães JDSS, de Morais JDP, Rugolo JM, Pontes KCJR, Dos Santos KAM, de Oliveira LS, Pinheiro LS, Pacheco LS, Sousa LD, Couto LSF, Kopittke L, de Moura LCS, Santos LEA, Cabral MAS, Souza MD, Tofani MGT, Carneiro M, Ferreira MAP, Bicalho MAC, Lima MCPB, Godoy MF, Cardoso MMA, Figueiredo MP, Sampaio NCS, Rangel NL, Crespo NT, de Oliveira NR, Assaf PL, Martelli PJL, Almeida RSC, Martins RC, Lutkmeier R, Valacio RA, Finger RG, Cardoso RB, Pozza R, Campos RX, Menezes RM, de Abreu RM, Silva RF, Guimarães SMM, Araújo SF, Pereira SA, Oliveira TF, Kurtz T, de Oliveira TC, Araújo TSMA, Diniz THO, Dos Santos VB, Gomes VMR, do Vale VAL, Ramires YC, Boersma E, and Polanczyk CA
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- Aged, Hospital Mortality, Hospitalization, Humans, Middle Aged, Prognosis, Retrospective Studies, Risk Factors, SARS-CoV-2, COVID-19
- Abstract
Objectives: The majority of available scores to assess mortality risk of coronavirus disease 2019 (COVID-19) patients in the emergency department have high risk of bias. Therefore, this cohort aimed to develop and validate a score at hospital admission for predicting in-hospital mortality in COVID-19 patients and to compare this score with other existing ones., Methods: Consecutive patients (≥ 18 years) with confirmed COVID-19 admitted to the participating hospitals were included. Logistic regression analysis was performed to develop a prediction model for in-hospital mortality, based on the 3978 patients admitted between March-July, 2020. The model was validated in the 1054 patients admitted during August-September, as well as in an external cohort of 474 Spanish patients., Results: Median (25-75th percentile) age of the model-derivation cohort was 60 (48-72) years, and in-hospital mortality was 20.3%. The validation cohorts had similar age distribution and in-hospital mortality. Seven significant variables were included in the risk score: age, blood urea nitrogen, number of comorbidities, C-reactive protein, SpO
2 /FiO2 ratio, platelet count, and heart rate. The model had high discriminatory value (AUROC 0.844, 95% CI 0.829-0.859), which was confirmed in the Brazilian (0.859 [95% CI 0.833-0.885]) and Spanish (0.894 [95% CI 0.870-0.919]) validation cohorts, and displayed better discrimination ability than other existing scores. It is implemented in a freely available online risk calculator (https://abc2sph.com/)., Conclusions: An easy-to-use rapid scoring system based on characteristics of COVID-19 patients commonly available at hospital presentation was designed and validated for early stratification of in-hospital mortality risk of patients with COVID-19., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2021
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32. COVID-19 seroprevalence in military police force, Southern Brazil.
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Pasqualotto AC, Pereira PC, Lana DFD, Schwarzbold AV, Ribeiro MS, Riche CVW, Castro CPP, Korsack PL, Ferreira PEB, Domingues GC, Ribeiro GT, Carneiro M, Caurio CFB, Vasconcellos ICDS, Knebel LM, Zamberlan L, Stolz AP, Vilanova M, Watte G, and Kalil AN
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- Adult, Brazil epidemiology, COVID-19 diagnosis, COVID-19 Serological Testing, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Military Personnel, Pandemics, Police, SARS-CoV-2 isolation & purification, Seroepidemiologic Studies, COVID-19 epidemiology
- Abstract
Background: Limited data is available regarding the frequency of COVID-19 in populations that are highly exposed to SARS-CoV-2. In this cross-section study we evaluated COVID-19 seroprevalence in military police forces of 10 major cities in Rio Grande do Sul, South of Brazil., Methods: Sampling was randomly performed in clusters, in respect to the number of professionals at service per city and military unit. Research subjects were evaluated on July 23, 2020 (first wave peak in Brazil). Clinical information was obtained, and venous blood was taken for ELISA testing (IgA, and IgG antibodies). Sample size consisted of 1,592 military workers (33.6% of study population). They were mostly man (81.2%) and young (median 34 years-old). Most had been asymptomatic (75.3%) during pandemic, and 27.5% reported close contact with COVID-19 cases (after a median time of 21 days). Antibodies were detected in 3.3% of the participants, mostly IgA (2.7%), and IgG (1.7%). After 3 weeks, 66.7% of IgA and IgG results turned negative, in addition to 78.3% and 100% of borderline IgA and IgG results, respectively., Conclusion: The seroprevalence of COVID-19 amongst military police was at least 3.4 higher than the findings of other studies performed in the general population, in the same cities and dates. Most detectable antibodies were of IgA class, which implies recent exposure. Asymptomatic people were more prone to have negative antibody titters in the second run., Competing Interests: The authors have declared that no competing interests exist.
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- 2021
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33. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials.
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Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Clutterbuck EA, Collins AM, Cutland CL, Darton TC, Dheda K, Dold C, Duncan CJA, Emary KRW, Ewer KJ, Flaxman A, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hill C, Hill HC, Hirsch I, Izu A, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Libri V, Lillie PJ, Marchevsky NG, Marshall RP, Mendes AVA, Milan EP, Minassian AM, McGregor A, Mujadidi YF, Nana A, Padayachee SD, Phillips DJ, Pittella A, Plested E, Pollock KM, Ramasamy MN, Ritchie AJ, Robinson H, Schwarzbold AV, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, White T, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, and Pollard AJ
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- Adolescent, Adult, Aged, Antibody Formation, Asymptomatic Infections, COVID-19 Vaccines adverse effects, ChAdOx1 nCoV-19, Humans, Middle Aged, Randomized Controlled Trials as Topic, SARS-CoV-2 immunology, Young Adult, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, COVID-19 Vaccines immunology, Immunization Schedule, Immunization, Secondary
- Abstract
Background: The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4-12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered., Methods: We present data from three single-blind randomised controlled trials-one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)-and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10
10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 1010 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005)., Findings: Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more than 14 days after the second dose. Overall vaccine efficacy more than 14 days after the second dose was 66·7% (95% CI 57·4-74·0), with 84 (1·0%) cases in the 8597 participants in the ChAdOx1 nCoV-19 group and 248 (2·9%) in the 8581 participants in the control group. There were no hospital admissions for COVID-19 in the ChAdOx1 nCoV-19 group after the initial 21-day exclusion period, and 15 in the control group. 108 (0·9%) of 12 282 participants in the ChAdOx1 nCoV-19 group and 127 (1·1%) of 11 962 participants in the control group had serious adverse events. There were seven deaths considered unrelated to vaccination (two in the ChAdOx1 nCov-19 group and five in the control group), including one COVID-19-related death in one participant in the control group. Exploratory analyses showed that vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 after vaccination was 76·0% (59·3-85·9). Our modelling analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 (geometric mean ratio [GMR] 0·66 [95% CI 0·59-0·74]). In the participants who received two standard doses, after the second dose, efficacy was higher in those with a longer prime-boost interval (vaccine efficacy 81·3% [95% CI 60·3-91·2] at ≥12 weeks) than in those with a short interval (vaccine efficacy 55·1% [33·0-69·9] at <6 weeks). These observations are supported by immunogenicity data that showed binding antibody responses more than two-fold higher after an interval of 12 or more weeks compared with an interval of less than 6 weeks in those who were aged 18-55 years (GMR 2·32 [2·01-2·68])., Interpretation: The results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the interim analysis of the trials and confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a programme with a short dose interval for roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose., Funding: UK Research and Innovation, National Institutes of Health Research (NIHR), The Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2021
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34. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
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Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, and Pollard AJ
- Subjects
- Adolescent, Adult, Aged, Brazil, ChAdOx1 nCoV-19, Double-Blind Method, Female, Humans, Male, Middle Aged, Single-Blind Method, South Africa, Treatment Outcome, United Kingdom, Young Adult, COVID-19 prevention & control, COVID-19 Vaccines adverse effects
- Abstract
Background: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials., Methods: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 10
10 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674., Findings: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation., Interpretation: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials., Funding: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2021
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35. CD4/CD8 ratio, comorbidities, and aging in treated HIV infected individuals on viral suppression.
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Passos DF, Bremm JM, da Silveira LL, Jantsch MH, da Silva JLG, Disconzi E, Rezer JFP, Schwarzbold AV, Marques ACF, Schetinger MRC, and Leal DBR
- Subjects
- Humans, Male, Female, Middle Aged, Adult, Anti-HIV Agents therapeutic use, Aged, CD4 Lymphocyte Count, CD8-Positive T-Lymphocytes immunology, Sustained Virologic Response, HIV Infections drug therapy, HIV Infections immunology, HIV Infections complications, HIV Infections virology, CD4-CD8 Ratio, Comorbidity, Aging immunology, Viral Load
- Abstract
The progression of the human immunodeficiency virus (HIV) infection to acquired immunodeficiency syndrome (AIDS) can be efficiently interrupted by antiretroviral therapy (ART). However, even successfully treated HIV-infected individuals are prone to develop non-AIDS-related diseases that affect the metabolism and several organs and systems. Biomarkers that predict the occurrence of comorbidities may help develop preventive measures. Current research shows that CD4
+ T cell counts and viral load do not predict the development of non-AIDS-related diseases. The CD4/CD8 ratio has been indicated as a suitable marker of persistent immune dysfunction and the occurrence of non-AIDS-related events in treated HIV-positive patients. In this study, we explored the relationship between CD4/CD8 ratios, comorbidities, and aging in ART-treated HIV patients on viral suppression. We collected and evaluated data from 352 HIV-positive adults who were virologically suppressed (<40 copies/mL) on ART and with CD4 counts above 350 cells/mm3 . The median age for participants was 46 years, 218 individuals had at least one comorbidity, and 239 had inverted CD4/CD8 ratios (<1). Current CD4/CD8 ratios were predicted by baseline CD4/CD8 ratios and nadir CD4 counts. Despite the high rates of inverted CD4/CD8 ratios and prevalence of comorbidities, no association between them was observed. The prevalence of comorbidities was significantly higher in older individuals, though aging alone did not explain the rate of all individual comorbidities. Low CD4/CD8 ratios were linked to neurocognitive disorders, suggesting that persistent T cell dysfunction contributes to neurocognitive decline., (© 2020 Wiley Periodicals, Inc.)- Published
- 2020
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36. Bordetella trematum infection: case report and review of previous cases.
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Y Castro TR, Martins RCR, Dal Forno NLF, Santana L, Rossi F, Schwarzbold AV, Costa SF, and Trindade PA
- Subjects
- Aged, Anti-Bacterial Agents therapeutic use, Bordetella Infections drug therapy, Bordetella Infections microbiology, Coinfection, Diabetic Foot complications, Diabetic Foot diagnosis, Diabetic Foot drug therapy, Diabetic Foot microbiology, Enterococcus faecalis isolation & purification, Fatal Outcome, Female, Gram-Negative Bacterial Infections complications, Gram-Negative Bacterial Infections diagnosis, Gram-Negative Bacterial Infections drug therapy, Gram-Negative Bacterial Infections microbiology, Gram-Positive Bacterial Infections complications, Gram-Positive Bacterial Infections diagnosis, Gram-Positive Bacterial Infections drug therapy, Gram-Positive Bacterial Infections microbiology, Humans, Intensive Care Units, Microbial Sensitivity Tests, Necrosis diagnosis, Necrosis microbiology, Piperacillin, Tazobactam Drug Combination therapeutic use, Stenotrophomonas maltophilia isolation & purification, Ulcer diagnosis, Ulcer microbiology, Bordetella isolation & purification, Bordetella Infections diagnosis
- Abstract
Background: Bordetella trematum is an infrequent Gram-negative coccobacillus, with a reservoir, pathogenesis, a life cycle and a virulence level which has been poorly elucidated and understood. Related information is scarce due to the low frequency of isolates, so it is important to add data to the literature about this microorganism., Case Presentation: We report a case of a 74-year-old female, who was referred to the hospital, presenting with ulcer and necrosis in both legs. Therapy with piperacillin-tazobactam was started and peripheral artery revascularization was performed. During the surgery, a tissue fragment was collected, where Bordetella trematum, Stenotrophomonas maltophilia, and Enterococcus faecalis were isolated. After surgery, the intubated patient was transferred to the intensive care unit (ICU), using vasoactive drugs through a central venous catheter. Piperacillin-tazobactam was replaced by meropenem, with vancomycin prescribed for 14 days. Four days later, levofloxacin was added for 24 days, aiming at the isolation of S. maltophilia from the ulcer tissue. The necrotic ulcers evolved without further complications, and the patient's clinical condition improved, leading to temporary withdrawal of vasoactive drugs and extubation. Ultimately, however, the patient's general condition worsened, and she died 58 days after hospital admission., Conclusions: Despite being a rare finding, B. trematum is typically associated with the clinical manifestation of disorders that predispose to ulcer development, which can be infected by microorganisms. The combination of antibiotic therapy and surgical debridement plays a key role in preventing systemic infections. Monitoring the appearance of new cases of B. trematum is essential, since it can be an emerging microorganism. Isolating and defining the clinical relevance of unusual bacteria yields a more accurate perspective in the development of new diagnostic tools and allows for assessment of proper antimicrobial therapy.
- Published
- 2019
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37. Histoplasmosis, An Underdiagnosed Disease Affecting People Living With HIV/AIDS in Brazil: Results of a Multicenter Prospective Cohort Study Using Both Classical Mycology Tests and Histoplasma Urine Antigen Detection.
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Falci DR, Monteiro AA, Braz Caurio CF, Magalhães TCO, Xavier MO, Basso RP, Melo M, Schwarzbold AV, Ferreira PRA, Vidal JE, Marochi JP, Godoy CSM, Soares RBA, Paste A, Bay MB, Pereira-Chiccola VL, Damasceno LS, Leitão TDMJS, and Pasqualotto AC
- Abstract
Background: Histoplasmosis is highly endemic in the American continent. This condition is associated with a high mortality, particularly in people living with HIV/AIDS (PLWHA). Diagnosis of histoplasmosis is usually late in South America, as Histoplasma antigen detection is rarely available. Here we determined the prevalence, risk factors, and outcome of histoplasmosis in PLWHA in Brazilian hospitals., Methods: This was a prospective cohort study (2016-2018) involving 14 tertiary medical centers in Brazil. We included hospitalized PLWHA presenting with fever and additional clinical findings. Patients were investigated at each participant center with classical mycology methods. Also, Histoplasma antigen detection was performed in urine samples (IMMY). Probable/proven histoplasmosis was defined according to European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group/National Institute of Allergy and Infectious Diseases Mycoses Study Group criteria., Results: From 616 eligible patients, 570 were included. Histoplasmosis was identified in 21.6% (123/570) of patients. Urine antigen testing increased the diagnostic yield in 53.8%, in comparison with standard mycology methods. Variables independently associated with histoplasmosis were CD4+ count <50 cells/mm
3 , use of an antiretroviral (protective effect), and sample collection in the Northeast region of Brazil. Dyspnea at presentation was independently associated with death. Histoplasmosis was more frequent than tuberculosis in patients with low CD4+ counts. Overall 30-day mortality was 22.1%, decreasing to 14.3% in patients with antigen-based diagnosis., Conclusions: Histoplasmosis is a very frequent condition affecting PLWHA in Brazil, particularly when CD4+ counts are lower than 50 cells/mm3 . Antigen detection may detect earlier disease, with a probable impact on outcomes. Access to this diagnostic tool is needed to improve clinical management of PLWHA in endemic countries.- Published
- 2019
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38. Vancomycin-resistant Enterococcus faecium Bacteremia in a tertiary care hospital: epidemiology, antimicrobial susceptibility, and outcome.
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Rosa RG, Schwarzbold AV, Dos Santos RP, Turra EE, Machado DP, and Goldani LZ
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- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Retrospective Studies, Tertiary Care Centers, Anti-Bacterial Agents administration & dosage, Bacteremia drug therapy, Bacteremia microbiology, Bacteremia mortality, Cross Infection drug therapy, Cross Infection microbiology, Cross Infection mortality, Enterococcus faecium, Gram-Positive Bacterial Infections drug therapy, Gram-Positive Bacterial Infections microbiology, Gram-Positive Bacterial Infections mortality, Vancomycin Resistance, Vancomycin-Resistant Enterococci
- Abstract
Vancomycin-resistant Enterococcus faecium (VREF) has emerged as a relevant multidrug-resistant pathogen and potentially lethal etiology of health care associated infections worldwide. The objective of this retrospective cohort study was to assess factors associated with mortality in patients with VREF bacteremia in a major tertiary referral hospital in Southern Brazil. All documented cases of bacteremia identified between May 2010 and July 2012 were evaluated. Cox regression was performed to determine whether the characteristics related to the host or antimicrobial treatment were associated with the all-cause 30-day mortality. In total, 35 patients with documented VREF bacteremia were identified during the study period. The median APACHE-II score of the study population was 26 (interquartile range: 10). The overall 30-day mortality was 65.7%. All VREF isolates were sensitive to linezolid, daptomycin, and quinupristin-dalfopristin. Linezolid was the only antimicrobial agent with in vitro activity against VREF that was administered to the cohort. After multivariate analysis, linezolid treatment (HR, 0.08; 95% CI, 0.02-0.27) and presence of acute kidney injury at the onset of bacteremia (HR, 4.01; 95% CI, 1.62-9.94) were independently associated with mortality. Presentation with acute kidney injury and lack of treatment with an effective antibiotic poses risk for mortality in patients with VREF bacteremia.
- Published
- 2014
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39. The influence of reperitonization on the induction of formation of intraperitoneal adhesions by a polypropylene mesh prosthesis. An experimental study in rats.
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Gurski RR, Schirmer CC, Wagner J, Berlim GL, Müller MF, Beck PE, Weidlich J, Teruchkin B, Schwarzbold AV, Leite CS, Tatsch MF, Saueressig M, Edelweiss MI, and Kruel CD
- Subjects
- Animals, Chi-Square Distribution, Laparoscopy, Male, Peritoneum surgery, Rats, Rats, Wistar, Wound Healing, Peritoneal Diseases etiology, Polypropylenes adverse effects, Postoperative Complications etiology, Surgical Mesh adverse effects, Tissue Adhesions etiology
- Abstract
The correction of groin hernias has increasingly been performed by transperitoneal videolaparoscopic methods, using a polypropylene mesh. This could lead to an increased incidence of adhesion formation. The incidence of adhesions induced by mesh placement and the influence of reperitonization was observed on 40 male adult Wistar rats. Adhesions were significantly more common on the groups in which the prosthesis was placed (59% vs 95%; p = 0.01), as well as on the groups in which reperitonization was performed (58% vs 100%; p = 0.03). The results suggest that polypropylene mesh placement and reperitonization are each independent factors in the induction of adhesions formation.
- Published
- 1998
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