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

Publication ,  Journal Article
O'Donnell, MR; Grinsztejn, B; Cummings, MJ; Justman, JE; Lamb, MR; Eckhardt, CM; Philip, NM; Cheung, YK; Gupta, V; João, E; Pilotto, JH ...
Published in: J Clin Invest
July 1, 2021

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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Published In

J Clin Invest

DOI

EISSN

1558-8238

Publication Date

July 1, 2021

Volume

131

Issue

13

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Severity of Illness Index
  • SARS-CoV-2
  • Pandemics
  • New York City
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Immunology
  • Immunization, Passive
 

Citation

APA
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O’Donnell, M. R., Grinsztejn, B., Cummings, M. J., Justman, J. E., Lamb, M. R., Eckhardt, C. M., … Lipkin, W. I. (2021). A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19. J Clin Invest, 131(13). https://doi.org/10.1172/JCI150646
O’Donnell, Max R., Beatriz Grinsztejn, Matthew J. Cummings, Jessica E. Justman, Matthew R. Lamb, Christina M. Eckhardt, Neena M. Philip, et al. “A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.J Clin Invest 131, no. 13 (July 1, 2021). https://doi.org/10.1172/JCI150646.
O’Donnell MR, Grinsztejn B, Cummings MJ, Justman JE, Lamb MR, Eckhardt CM, et al. A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19. J Clin Invest. 2021 Jul 1;131(13).
O’Donnell, Max R., et al. “A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.J Clin Invest, vol. 131, no. 13, July 2021. Pubmed, doi:10.1172/JCI150646.
O’Donnell MR, Grinsztejn B, Cummings MJ, Justman JE, Lamb MR, Eckhardt CM, Philip NM, Cheung YK, Gupta V, João E, Pilotto JH, Diniz MP, Cardoso SW, Abrams D, Rajagopalan KN, Borden SE, Wolf A, Sidi LC, Vizzoni A, Veloso VG, Bitan ZC, Scotto DE, Meyer BJ, Jacobson SD, Kantor A, Mishra N, Chauhan LV, Stone EF, Dei Zotti F, La Carpia F, Hudson KE, Ferrara SA, Schwartz J, Stotler BA, Lin W-HW, Wontakal SN, Shaz B, Briese T, Hod EA, Spitalnik SL, Eisenberger A, Lipkin WI. A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19. J Clin Invest. 2021 Jul 1;131(13).

Published In

J Clin Invest

DOI

EISSN

1558-8238

Publication Date

July 1, 2021

Volume

131

Issue

13

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Severity of Illness Index
  • SARS-CoV-2
  • Pandemics
  • New York City
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Immunology
  • Immunization, Passive