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. 2022 May;62(5):933-941.
doi: 10.1111/trf.16871. Epub 2022 Apr 4.

How do I implement an outpatient program for the administration of convalescent plasma for COVID-19?

Evan M Bloch  1 , Aaron A R Tobian  1 , Shmuel Shoham  2 , Daniel F Hanley  3 , Thomas J Gniadek  4 , Edward R Cachay  5 , Barry R Meisenberg  6 , Kimberly Kafka  7 , Christi Marshall  3 , Sonya L Heath  8 , Aarthi Shenoy  9 , James H Paxton  10 , Adam Levine  11 , Donald Forthal  12 , Yuriko Fukuta  13 , Moises A Huaman  14 , Alyssa Ziman  15 , Jill Adamski  16 , Jonathan Gerber  17 , Daniel Cruser  18 , Seble G Kassaye  19 , Giselle S Mosnaim  20 , Bela Patel  21 , Ryan A Metcalf  22 , Shweta Anjan  23 , Ronald B Reisler  24 , Anusha Yarava  3 , Karen Lane  3 , Nichol McBee  3 , Amy Gawad  3 , Jay S Raval  25 , Martin Zand  26 , Matthew Abinante  27 , Patrick B Broderick  28 , Arturo Casadevall  29 , David Sullivan  29 , Kelly A Gebo  2
Affiliations

How do I implement an outpatient program for the administration of convalescent plasma for COVID-19?

Evan M Bloch et al. Transfusion. 2022 May.

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.

Keywords: COVID-19; COVID-19 serotherapy; ambulatory care; antibodies; blood transfusion; monoclonal; plasma.

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Conflict of interest statement

Evan M. Bloch reports personal fees and non‐financial support from Terumo BCT, Grifols Diagnostic Solutions, and Abbott Laboratories, outside of the submitted work; Evan M. Bloch is a member of the United States Food and Drug Administration (FDA) Blood Products Advisory Committee. Any views or opinions that are expressed in this manuscript are those of the author's, based on his own scientific expertise and professional judgment; they do not necessarily represent the views of either the Blood Products Advisory Committee or the formal position of the FDA, and do not bind or otherwise obligate or commit either Advisory Committee or the Agency to the views expressed.

Figures

FIGURE 1
FIGURE 1
Workflow of outpatient transfusion of convalescent plasma
FIGURE 2
FIGURE 2
Photographs of an outpatient infusion site. (A) Pod for clinical staff workspace. (B) Exterior of patient infusion pods. (C) Donning and doffing stations and computer for entering vitals outside of patient infusion room. (D) Patient infusion room with chair and exam table, crash cart, oxygen, and equipment for infusion and assessment of vital signs. (E) Transportation coolers for samples to go to blood bank laboratory and coolers to be returned to blood bank after plasma infusion. (F) COVID‐19 safe transportation for patients to and from infusion site [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

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