Early Outpatient Treatment for Covid-19 with Convalescent Plasma.
Sullivan, David J. M.D.; Gebo, Kelly A. M.D., M.P.H.; Shoham, Shmuel M.D.; Bloch, Evan M. M.B., Ch.B.; Lau, Bryan Ph.D.; Shenoy, Aarthi G. M.D.; Mosnaim, Giselle S. M.D.; Gniadek, Thomas J. M.D., Ph.D.; Fukuta, Yuriko M.D., Ph.D.; Patel, Bela M.D.; Heath, Sonya L. M.D.; Levine, Adam C. M.D., M.P.H.; Meisenberg, Barry R. M.D.; Spivak, Emily S. M.D.; Anjan, Shweta M.D.; Huaman, Moises A. M.D.; Blair, Janis E. M.D.; Currier, Judith S. M.D.; Paxton, James H. M.D.; Gerber, Jonathan M. M.D.; Petrini, Joann R. Ph.D., M.P.H.; Broderick, Patrick B. M.D.; Rausch, William Sc.B., C.I.P.; Cordisco, Marie-Elena M.A.; Hammel, Jean M.D.; Greenblatt, Benjamin M.D.; Cluzet, Valerie C. M.D.; Cruser, Daniel M.D.; Oei, Kevin D.O.; Abinante, Matthew D.O., M.P.H.; Hammitt, Laura L. M.D.; Sutcliffe, Catherine G. Ph.D.; Forthal, Donald N. M.D.; Zand, Martin S. M.D.; Cachay, Edward R. M.D.; Raval, Jay S. M.D.; Kassaye, Seble G. M.D.; Foster, Colin E.; Roth, Michael; Marshall, Christi E.; Yarava, Anusha Pharm.D.; Lane, Karen C.C.R.P.; McBee, Nichol A. M.P.H.; Gawad, Amy L. M.P.H.; Karlen, Nicky; Singh, Atika M.S.P.H.; Ford, Daniel E. M.D., Ph.D.; Jabs, Douglas A. M.D., M.B.A.; Appel, Lawrence J. M.D., M.P.H.; Shade, David M. J.D.; Ehrhardt, Stephan M.D., M.P.H.; Baksh, Sheriza N. Ph.D., M.P.H.; Laeyendecker, Oliver Ph.D., M.B.A.; Pekosz, Andrew Ph.D.; Klein, Sabra L. Ph.D.; Casadevall, Arturo M.D., Ph.D.; Tobian, Aaron A.R. M.D., Ph.D.; Hanley, Daniel F. M.D.
[Article]
New England Journal of Medicine.
386(18):1700-1711, May 5, 2022.
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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.)
Convalescent Plasma for Early SARS-CoV-2 Infection: In this multicenter, double-blind trial of convalescent plasma for early, symptomatic SARS-CoV-2 infection, 1225 patients were randomly assigned to receive convalescent plasma or control plasma within 9 days after the onset of symptoms. Significantly fewer recipients of convalescent plasma had progression of Covid-19-associated illness leading to hospitalization.
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