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
Shmuel Shoham, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Daniel F. Hanley, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Thomas J. Gniadek, Department of Pathology, Northshore University Health System, Evanston, Illinois, USA
Edward R. Cachay, Department of Medicine, Division of Infectious Diseases, University of California, San Diego, California, United States
Barry R. Meisenberg, Luminis Health, Annapolis, Maryland, USA
Kimberly Kafka, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Christi Marshall, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Sonya L. Heath, Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA
Aarthi Shenoy, Department of Medicine, Division of Hematology and Oncology, Medstar Washington Hospital Center, Washington, District of Columbia, USA
James H. Paxton, Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA
Adam Levine, Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, Rhode Island, USA
Donald Forthal, Department of Medicine, Division of Infectious Diseases, University of California, Irvine, California, United States
Yuriko Fukuta, Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA
Moises A. Huaman, Department of Laboratory Medicine, Mayo Clinic Hospital, Phoenix, Arizona, USA
Alyssa Ziman, Department of Pathology, University of California, Los Angeles, California, USA
Jill Adamski, Department of Laboratory Medicine, Mayo Clinic Hospital, Phoenix, Arizona, USA.
Jonathan Gerber, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, Massachusetts, USA
Daniel Cruser, Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA
Seble G. Kassaye, Department of Medicine, Division of Infectious Diseases, Medstar Georgetown University Hospital, Washington, District of Columbia, USA
Giselle S. Mosnaim, Division of Allergy and Immunology, Department of Medicine, Northshore University Health System, Evanston, Illinois, USA
Bela Patel, Department of Medicine, Divisions of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, Texas, USA
Ryan A. Metcalf, Department of Medicine, Division of Infectious Diseases, University of Utah, Salt Lake City, Utah, USA
Shweta Anjan, Department of Medicine, Division of Infectious Diseases, University of Miami, Miller School of Medicine, Miami, Florida, USA
Ronald B. Reisler, Davis Defense Group, Stafford, Virginia, USA
Anusha Yarava, 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 McBee, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Amy Gawad, Department of Neurology, Brain Injury Outcomes Division, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Jay S. Raval, Department of Pathology, University of New Mexico, Albuquerque, New Mexico, USA
Martin Zand, Department of Medicine, University of Rochester, Rochester, New York, USA
Matthew Abinante, Ascada Research, Fullerton, California, USA
Patrick B. Broderick, Nuvance Health Danbury Hospital, Danbury, Connecticut, USA
Arturo Casadevall, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
David Sullivan, Departments of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
Kelly A. Gebo, Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

Document Type

Article

Publication Date

5-1-2022

Abstract

Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies.

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