A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.

Autor: O'Donnell MR; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.; Department of Epidemiology, and.; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA., Grinsztejn B; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil., Cummings MJ; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA., Justman JE; Department of Epidemiology, and.; 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., Lamb MR; Department of Epidemiology, and.; ICAP, Columbia University Mailman School of Public Health, New York, New York, USA., Eckhardt CM; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Philip NM; ICAP, Columbia University Mailman School of Public Health, New York, New York, USA., Cheung YK; Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA., Gupta V; Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington, USA., João E; Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil., Pilotto JH; Hospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil and Laboratório de Aids e Imunologia Molecular, Instituto Oswaldo Cruz - Fiocruz, Rio de Janeiro, Brazil., Diniz MP; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil., Cardoso SW; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil., Abrams D; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Rajagopalan KN; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Borden SE; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Wolf A; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Sidi LC; Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil., Vizzoni A; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil., Veloso VG; Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil., Bitan ZC; Department of Pathology and Cell Biology, 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; Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA., Jacobson SD; Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA., Kantor A; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Mishra N; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA., Chauhan LV; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA., Stone EF; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA., Dei Zotti F; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA., La Carpia F; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA., Hudson KE; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA., Ferrara SA; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA., Schwartz J; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, 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; New York Blood Center, New York, New York, USA., Briese T; Center for Infection and Immunity, Columbia University Mailman School of Public Health, 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; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA., Lipkin WI; Department of Epidemiology, and.; Center for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.; Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Jazyk: angličtina
Zdroj: The Journal of clinical investigation [J Clin Invest] 2021 Jul 01; Vol. 131 (13).
DOI: 10.1172/JCI150646
Abstrakt: 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.
Databáze: MEDLINE