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N Engl J Med
. 2022 Mar 30.
doi: 10.1056/NEJMoa2119657. Online ahead of print.
Early Outpatient Treatment for Covid-19 with Convalescent Plasma
David J Sullivan 1 , Kelly A Gebo 1 , Shmuel Shoham 1 , Evan M Bloch 1 , Bryan Lau 1 , Aarthi G Shenoy 1 , Giselle S Mosnaim 1 , Thomas J Gniadek 1 , Yuriko Fukuta 1 , Bela Patel 1 , Sonya L Heath 1 , Adam C Levine 1 , Barry R Meisenberg 1 , Emily S Spivak 1 , Shweta Anjan 1 , Moises A Huaman 1 , Janis E Blair 1 , Judith S Currier 1 , James H Paxton 1 , Jonathan M Gerber 1 , Joann R Petrini 1 , Patrick B Broderick 1 , William Rausch 1 , Marie-Elena Cordisco 1 , Jean Hammel 1 , Benjamin Greenblatt 1 , Valerie C Cluzet 1 , Daniel Cruser 1 , Kevin Oei 1 , Matthew Abinante 1 , Laura L Hammitt 1 , Catherine G Sutcliffe 1 , Donald N Forthal 1 , Martin S Zand 1 , Edward R Cachay 1 , Jay S Raval 1 , Seble G Kassaye 1 , E Colin Foster 1 , Michael Roth 1 , Christi E Marshall 1 , Anusha Yarava 1 , Karen Lane 1 , Nichol A McBee 1 , Amy L Gawad 1 , Nicky Karlen 1 , Atika Singh 1 , Daniel E Ford 1 , Douglas A Jabs 1 , Lawrence J Appel 1 , David M Shade 1 , Stephan Ehrhardt 1 , Sheriza N Baksh 1 , Oliver Laeyendecker 1 , Andrew Pekosz 1 , Sabra L Klein 1 , Arturo Casadevall 1 , Aaron A R Tobian 1 , Daniel F Hanley 1
Affiliations
- PMID: 35353960
- DOI: 10.1056/NEJMoa2119657
Abstract
Background: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
Methods: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.
Results: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.
Conclusions: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
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