Moises A. Huaman, Department of Internal Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA.
Jay S. Raval, Department of Pathology, University of New Mexico School of Medicine, Albuquerque, New Mexico, USA.
James H. Paxton, Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.
Giselle S. Mosnaim, Department of Medicine, Division of Allergy and Immunology, NorthShore University Health System, Evanston, Illinois, USA.
Bela Patel, Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, Texas, USA.
Shweta Anjan, Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
Barry R. Meisenberg, Luminis Health, Annapolis, Maryland, USA.
Adam C. Levine, Department of Emergency Medicine, Rhode Island Hospital & Brown University, Providence, Rhode Island, USA.
Christi E. Marshall, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Anusha Yarava, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Aarthi G. Shenoy, Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, DC, USA.
Sonya L. Heath, Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Judith S. Currier, Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, USA.
Yuriko Fukuta, Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA.
Janis E. Blair, Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona, USA.
Emily S. Spivak, Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Joann R. Petrini, Nuvance Health, Danbury, Connecticut, USA.
Patrick B Broderick, Nuvance Health Danbury Hospital, Danbury, Connecticut, USA.
William Rausch, Nuvance Health, Danbury, Connecticut, USA.
MarieElena Cordisco, Nuvance Health, Danbury, Connecticut, USA.
Jean Hammel, Nuvance Health Norwalk Hospital, Norwalk, Connecticut, USA.
Benjamin Greenblatt, Nuvance Health Norwalk Hospital, Norwalk, Connecticut, USA.
Valerie C Cluzet, Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA.
Daniel Cruser, Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA.
Kevin Oei, Ascada Research, Fullerton, California, USA.
Matthew Abinante, Ascada Research, Fullerton, California, USA.
Laura L. Hammitt, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Catherine G. Sutcliffe, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Donald N. Forthal, Department of Medicine, Division of Infectious Diseases, University of California, Irvine, California, USA.
Martin S Zand, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Edward R. Cachay, Department of Medicine, Division of Infectious Diseases, University of California, San Diego, California, USA.
Seble G. Kassaye, Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, DC, USA.
Malathi Ram, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Ying Wang, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Piyali Das, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Karen Lane, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Nichol A McBee, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Amy L Gawad, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Nicky Karlen, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Daniel E Ford, Institute for Clinical and Translational Research, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Oliver Laeyendecker, The Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
Andrew Pekosz, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Sabra L. Klein, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Stephan Ehrhardt, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Bryan Lau, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Sheriza N. Baksh, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
David M. Shade, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Arturo Casadevall, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Daniel F. Hanley, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Jiangda Ou, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Thomas J. Gniadek, Department of Pathology and Laboratory Medicine, NorthShore University Health System, Evanston, Illinois, USA.
Alyssa Ziman, Department of Pathology and Laboratory Medicine, Wing-Kwai and Alice Lee-Tsing Chung Transfusion Service, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
Shmuel Shoham, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kelly A. Gebo, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Evan M. Bloch, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Aaron A R Tobian, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
David J. Sullivan, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Jonathan M. Gerber, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.

Document Type

Article

Publication Date

9-1-2023

Abstract

BACKGROUND: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials.

STUDY DESIGN AND METHODS: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders.

RESULTS: The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications.

DISCUSSION: Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.

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