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A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL OF CONVALESCENT PLASMA IN ADULTS WITH SEVERE COVID-19
Convalescent plasma
Adults
Severe COVID-19
Controlled trial
Autor(es)
O’Donnell, Max R.
Grinsztejn, Beatriz
Cummings, Matthew J.
Justman, Jessica E.
Lamb, Matthew R.
Eckhardt, Christina M.
Philip, Neena M.
Cheung, Ying Kuen
Gupta, Vinay
João, Esau
Pilotto, José Henrique
Diniz, Maria Pia
Cardoso, Sandra Wagner
Abrams, Darryl
Rajagopalan, Kartik N.
Borden, Sarah E.
Wolf, Allison
Sidi, Leon Claude
Vizzoni, Alexandre
Veloso, Valdiléa G.
Bitan, Zahary C.
Scotto, Dawn E.
Meyer, Benjamin J.
Jacobson, Samuel D.
Kantor, Alex
Mishra, Nischay
Chauhan, Lokendra V
Stone, Elizabeth F.
Dei Zotti, Flavia
La Carpia, Francesca
Hudson, Krystalyn E.
Ferrara, Stephen A.
Schwartz, Joseph
Stotler, Brie A.
Lin, Wen-Hsuan W.
Wontakal, Sandeep N.
Shaz, Beth
Briese, Thomas
Hod, Eldad A.
Spitalnik, Steven L
Eisenberger, Andrew
Lipkin, Walter I.
Grinsztejn, Beatriz
Cummings, Matthew J.
Justman, Jessica E.
Lamb, Matthew R.
Eckhardt, Christina M.
Philip, Neena M.
Cheung, Ying Kuen
Gupta, Vinay
João, Esau
Pilotto, José Henrique
Diniz, Maria Pia
Cardoso, Sandra Wagner
Abrams, Darryl
Rajagopalan, Kartik N.
Borden, Sarah E.
Wolf, Allison
Sidi, Leon Claude
Vizzoni, Alexandre
Veloso, Valdiléa G.
Bitan, Zahary C.
Scotto, Dawn E.
Meyer, Benjamin J.
Jacobson, Samuel D.
Kantor, Alex
Mishra, Nischay
Chauhan, Lokendra V
Stone, Elizabeth F.
Dei Zotti, Flavia
La Carpia, Francesca
Hudson, Krystalyn E.
Ferrara, Stephen A.
Schwartz, Joseph
Stotler, Brie A.
Lin, Wen-Hsuan W.
Wontakal, Sandeep N.
Shaz, Beth
Briese, Thomas
Hod, Eldad A.
Spitalnik, Steven L
Eisenberger, Andrew
Lipkin, Walter I.
Afiliação
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA / Columbia University Mailman School of Public Health. Department of Epidemiology. New York, New York, USA / Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA / Columbia University Mailman School of Public Health. Center for Infection and Immunity. New York, NY, USA
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, New York, USA / Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, NY, USA
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, NY, USA.
ICAP, Columbia University Mailman School of Public Health, New York, NY, USA.
Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY. USA.
Institute for Health Metrics and Evaluation, University of Washington. Seattle, Washington, USA. .
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Aids e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Department of Pathology and Cell Biology, Columbia University Irving Medical Center. New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Vagelos College of Physicians and Surgeons, Columbia University. New York, NY, USA.
Vagelos College of Physicians and Surgeons, Columbia University. New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA.
Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
New York Blood Center. New York, NY, USA
Columbia University Mailman School of Public Health. Center for Infection and Immunity. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Division of Hematology and Oncology, Department of Medicine, Columbia University. New York, NY, USA.
Columbia University Mailman School of Public Health. Department of Epidemiology. New York, New York, USA / Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA / Department of Pathology and Cell Biology, Columbia University Irving Medical Center. New York, NY, USA .
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA / Columbia University Mailman School of Public Health. Center for Infection and Immunity. New York, NY, USA
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, New York, USA / Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, NY, USA
Columbia University Mailman School of Public Health; Department of Epidemiology. New York, NY, USA / ICAP, Columbia University Mailman School of Public Health, New York, NY, USA.
ICAP, Columbia University Mailman School of Public Health, New York, NY, USA.
Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY. USA.
Institute for Health Metrics and Evaluation, University of Washington. Seattle, Washington, USA. .
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Aids e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Department of Pathology and Cell Biology, Columbia University Irving Medical Center. New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Vagelos College of Physicians and Surgeons, Columbia University. New York, NY, USA.
Vagelos College of Physicians and Surgeons, Columbia University. New York, NY, USA.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA.
Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
New York Blood Center. New York, NY, USA
Columbia University Mailman School of Public Health. Center for Infection and Immunity. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Columbia University Irving Medical Center. Department of Pathology and Cell Biology. New York, NY, USA.
Division of Hematology and Oncology, Department of Medicine, Columbia University. New York, NY, USA.
Columbia University Mailman School of Public Health. Department of Epidemiology. New York, New York, USA / Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, NY, USA / Department of Pathology and Cell Biology, Columbia University Irving Medical Center. New York, NY, USA .
Resumo em Inglês
BACKGROUND. Although convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data
from randomized controlled trials that support its efficacy are limited.
METHODS. We conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical
COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single
transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28
days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the
intention-to-treat population.
RESULTS. Of 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal
control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized
to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83–2.68, P = 0.180). However, 28-day mortality was
significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73
[24.6%], OR 0.44, 95% CI 0.22–0.91, P = 0.034). The median titer of anti–SARS-CoV-2 neutralizing antibody in infused
convalescent plasma units was 1:160 (IQR 1:80–1:320). In a subset of nasopharyngeal swab samples from Brazil that
underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.
CONCLUSION. In adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant
improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A
possible explanation is that survivors remained hospitalized at their baseline clinical status.
Palavras-chave em inglês
Randomized double-blindConvalescent plasma
Adults
Severe COVID-19
Controlled trial
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