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A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.
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, Jose Henrique; Diniz, Maria Pia; Cardoso, Sandra Wagner; Abrams, Darryl; Rajagopalan, Kartik N; Borden, Sarah E; Wolf, Allison; Sidi, Leon Claude; Vizzoni, Alexandre; Veloso, Valdilea G; Bitan, Zachary 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
  • O'Donnell MR; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Grinsztejn B; Department of Epidemiology, and.
  • Cummings MJ; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Justman JE; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
  • Lamb MR; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Eckhardt CM; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Philip NM; Department of Epidemiology, and.
  • Cheung YK; ICAP, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Gupta V; Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • João E; Department of Epidemiology, and.
  • Pilotto JH; ICAP, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Diniz MP; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Cardoso SW; ICAP, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Abrams D; Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Rajagopalan KN; Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington, USA.
  • Borden SE; Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
  • Wolf A; Hospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil and Laboratório de Aids e Imunologia Molecular, Instituto Oswaldo Cruz - Fiocruz, Rio de Janeiro, Brazil.
  • Sidi LC; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
  • Vizzoni A; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
  • Veloso VG; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Bitan ZC; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Scotto DE; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Meyer BJ; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Jacobson SD; Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
  • Kantor A; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
  • Mishra N; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
  • Chauhan LV; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Stone EF; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Dei Zotti F; Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.
  • La Carpia F; Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.
  • Hudson KE; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Ferrara SA; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Schwartz J; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
  • Stotler BA; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Lin WW; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Wontakal SN; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Shaz B; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Briese T; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Hod EA; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Spitalnik SL; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Eisenberger A; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Lipkin WI; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
J Clin Invest ; 131(13)2021 07 01.
Article em En | MEDLINE | ID: mdl-33974559
BACKGROUNDAlthough 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.METHODSWe 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.RESULTSOf 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.CONCLUSIONIn 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.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: SARS-CoV-2 / COVID-19 Tipo de estudo: Clinical_trials Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Região como assunto: America do norte / America do sul / Brasil Idioma: En Revista: J Clin Invest Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: SARS-CoV-2 / COVID-19 Tipo de estudo: Clinical_trials Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Região como assunto: America do norte / America do sul / Brasil Idioma: En Revista: J Clin Invest Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Estados Unidos