David J. Sullivan, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MDEpidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Kelly A. Gebo, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine
Shmuel Shoham, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine
Bryan Lau, Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Aarthi G G Shenoy, Department of Medicine, Division of Hematology and Oncology, Medstar Washington Hospital Center, Washington, DC
Giselle S. Mosnaim, Division of Allergy and Immunology, Department of Medicine, Northshore University Health System, Evanston, IL
Thomas J. Gniadek, Department of Pathology, Northshore University Health System, Evanston, IL
Yuriko Fukuta, Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX
Bela Patel, Department of Medicine, Divisions of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, TX
Sonya L. Heath, Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL
Adam C. Levine, Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI
Barry R. Meisenberg, Luminis Health, Annapolis, MD
Emily S. Spivak, Department of Medicine, Division of Infectious Diseases, University of Utah, Salt Lake City, UT
Shweta Anjan, Department of Medicine, Division of Infectious Diseases, University of Miami, Miller School of Medicine, Miami, FL
Moises A. Huaman, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH
Janis E. Blair, Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ
Judith S. Currier, Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA
James H. Paxton, Department of Emergency Medicine, Wayne State University, Detroit, MI
Jonathan M. Gerber, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA
Joann R. Petrini, Nuvance Health, Danbury, CT
Patrick B. Broderick, Nuvance Health Danbury Hospital, Danbury, CT
William Rausch, Nuvance Health, Danbury, CT
Marie Elena Cordisco, Nuvance Health, Danbury, CT
Jean Hammel, uvance Health Norwalk Hospital, Norwalk, CT
Benjamin Greenblatt, uvance Health Norwalk Hospital, Norwalk, CT
Daniel Cruser, Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY
Kevin Oei, Ascada Research, Fullerton, CA
Matthew Abinante, Ascada Research, Fullerton, CA
Laura L. Hammitt, International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Catherine G. Sutcliffe, International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Donald N. Forthal, Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA
Martin S. Zand, Department of Medicine, University of Rochester, Rochester, NY
Edward R. Cachay, Department of Medicine, Division of Infectious Diseases, University of California, San Diego, San Diego, CA
Jay S. Raval, Department of Pathology, University of New Mexico, Albuquerque, NM
Seble G. Kassaye, Department of Medicine, Division of Infectious Diseases, Medstar Georgetown University Hospital, Washington, D.C
E Colin Foster, The Next Practice, Austin, TX
Michael Roth, The Bliss Group, New York City, NY
Christi E. Marshall, Department of Pathology, Johns Hopkins University School of Medicine
Anusha Yarava, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Karen Lane, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Nichol A. McBee, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Amy L. Gawad, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Nicky Karlen, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Atika Singh
Daniel E. Ford, Institute for Clinical and Translational Research, Johns Hopkins University School of Medicine
Douglas A. Jabs, Department of Ophthalmology, Johns Hopkins University School of Medicine
Lawrence J. Appel, Welch Center, Johns Hopkins University School of Medicine
David M. Shade, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MDEpidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Stephan Ehrhardt, Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Sheriza N. Baksh, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH
Oliver Laeyendecker, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH
Andrew Pekosz, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Sabra L. Klein, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Arturo Casadevall, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD
Aaron A R Tobian, Department of Pathology, Johns Hopkins University School of Medicine
Daniel F. Hanley, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine
Evan M. Bloch, Department of Pathology, Johns Hopkins University School of Medicine
Valerie C. Cluzet, Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY

Document Type

Article

Publication Date

12-21-2021

Abstract

BACKGROUND: The efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain.

METHODS: This multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in symptomatic adults ≥18 years positive for SARS-CoV-2 regardless of risk factors for disease progression or vaccine status. Participants with symptom onset within 8 days were enrolled, then transfused within the subsequent day. The measured primary outcome was COVID-19-related hospitalization within 28 days of plasma transfusion. The enrollment period was June 3, 2020 to October 1, 2021.

RESULTS: A total of 1225 participants were randomized and 1181 transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) who received placebo control plasma and in 17 of 592 (2.9%) participants who received convalescent plasma (relative risk, 0.46; one-sided 95% upper bound confidence interval 0.733; P=0.004) corresponding to a 54% risk reduction. Examination with a model adjusting for covariates related to the outcome did not change the conclusions.

CONCLUSION: Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic.

TRIAL REGISTRATION: ClinicalTrials.gov number, NCT04373460 .

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