• David J Sullivan, Kelly A Gebo, Shmuel Shoham, Evan M Bloch, Bryan Lau, Aarthi G Shenoy, Giselle S Mosnaim, Thomas J Gniadek, Yuriko Fukuta, Bela Patel, Sonya L Heath, Adam C Levine, Barry R Meisenberg, Emily S Spivak, Shweta Anjan, Moises A Huaman, Janis E Blair, Judith S Currier, James H Paxton, Jonathan M Gerber, Joann R Petrini, Patrick B Broderick, William Rausch, Marie-Elena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie C Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura L Hammitt, Catherine G Sutcliffe, Donald N Forthal, Martin S Zand, Edward R Cachay, Jay S Raval, Seble G Kassaye, E Colin Foster, Michael Roth, Christi E Marshall, Anusha Yarava, Karen Lane, Nichol A McBee, Amy L Gawad, Nicky Karlen, Atika Singh, Daniel E Ford, Douglas A Jabs, Lawrence J Appel, David M Shade, Stephan Ehrhardt, Sheriza N Baksh, Oliver Laeyendecker, Andrew Pekosz, Sabra L Klein, Arturo Casadevall, TobianAaron A RAARFrom the Department of Medicine, Division of Infectious Diseases (K.A.G., S.S.), the Department of Pathology (E.M.B., C.E.M., A.A.R.T.), the Department of Neurology, Brain Injury Outcomes Division (A.Y., K.L., N.A.M., A.L.G., N.K., D.F.H, and Daniel F Hanley.
• From the Department of Medicine, Division of Infectious Diseases (K.A.G., S.S.), the Department of Pathology (E.M.B., C.E.M., A.A.R.T.), the Department of Neurology, Brain Injury Outcomes Division (A.Y., K.L., N.A.M., A.L.G., N.K., D.F.H.), the Department of Ophthalmology (D.A.J.), the Welch Center for Prevention, Epidemiology and Clinical Research (L.J.A.), and the Institute for Clinical and Translational Research (D.E.F.), Johns Hopkins School of Medicine, and the Departments of Molecular Microbiology and Immunology (D.J.S., A.S., A.P., S.L.K., A.C.), International Health (L.L.H., C.G.S.), and Epidemiology (B.L., D.M.S., S.E., S.N.B.), Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda (O.L.), and Luminis Health, Annapolis (B.R.M.) - all in Maryland; the Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center (A.G.S.), and the Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center (S.G.K.) - both in Washington, DC; the Division of Allergy and Immunology, Department of Medicine (G.S.M.), and the Department of Pathology (T.J.G.), NorthShore University Health System, Evanston, IL; the Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine (Y.F.), the Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center (B.P.), Houston, and The Next Practices Group, Austin (E.C.F.) - all in Texas; the Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham (S.L.H.); the Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI (A.C.L.); the Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City (E.S.S.); the Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami (S.A.); the Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati (M.A.H.); the Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ (J.E.B.); the Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles (J.S.C.), Ascada Research (K.O., M.A.), the Department of Medicine, Division of Infectious Diseases, University of California, Irvine (D.N.F.), and the Department of Medicine, Division of Infectious Diseases, University of California, San Diego (E.R.C.) - all in California; the Department of Emergency Medicine, Wayne State University, Detroit (J.H.P.); the Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester (J.M.G.); Nuvance Health (J.R.P., W.R., M.-E.C.), and Nuvance Health Danbury Hospital (P.B.B.), Danbury, and Nuvance Health Norwalk Hospital, Norwalk (J.H., B.G.) - all in Connecticut; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie (V.C.C., D.C.), the Department of Medicine, University of Rochester Medical Center, Rochester (M.S.Z.), and the Bliss Group, New York (M.R.) - all in New York; and the Department of Pathology, University of New Mexico School of Medicine, Albuquerque, NM (J.S.R.).
• N. Engl. J. Med. 2022 May 5; 386 (18): 170017111700-1711.

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.).Copyright © 2022 Massachusetts Medical Society.

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