학술논문
Early Outpatient Treatment for Covid-19 with Convalescent Plasma
Document Type
article
Author
Sullivan, David J; Gebo, Kelly A; Shoham, Shmuel; Bloch, Evan M; Lau, Bryan; Shenoy, Aarthi G; Mosnaim, Giselle S; Gniadek, Thomas J; Fukuta, Yuriko; Patel, Bela; Heath, Sonya L; Levine, Adam C; Meisenberg, Barry R; Spivak, Emily S; Anjan, Shweta; Huaman, Moises A; Blair, Janis E; Currier, Judith S; Paxton, James H; Gerber, Jonathan M; Petrini, Joann R; Broderick, Patrick B; Rausch, William; Cordisco, Marie-Elena; Hammel, Jean; Greenblatt, Benjamin; Cluzet, Valerie C; Cruser, Daniel; Oei, Kevin; Abinante, Matthew; Hammitt, Laura L; Sutcliffe, Catherine G; Forthal, Donald N; Zand, Martin S; Cachay, Edward R; Raval, Jay S; Kassaye, Seble G; Foster, E Colin; Roth, Michael; Marshall, Christi E; Yarava, Anusha; Lane, Karen; McBee, Nichol A; Gawad, Amy L; Karlen, Nicky; Singh, Atika; Ford, Daniel E; Jabs, Douglas A; Appel, Lawrence J; Shade, David M; Ehrhardt, Stephan; Baksh, Sheriza N; Laeyendecker, Oliver; Pekosz, Andrew; Klein, Sabra L; Casadevall, Arturo; Tobian, Aaron AR; Hanley, Daniel F
Source
New England Journal of Medicine. 386(18)
Subject
Language
Abstract
BackgroundPolyclonal 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.MethodsIn 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.ResultsParticipants 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.ConclusionsIn 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.).