Title
How do I implement an outpatient program for the administration of convalescent plasma for COVID-19?
Date Issued
01 May 2022
Access level
open access
Resource Type
journal article
Author(s)
Bloch E.M.
Tobian A.A.R.
Shoham S.
Hanley D.F.
Gniadek T.J.
Cachay E.R.
Meisenberg B.R.
Kafka K.
Marshall C.
Heath S.L.
Shenoy A.
Paxton J.H.
Levine A.
Forthal D.
Fukuta Y.
Huaman M.A.
Ziman A.
Adamski J.
Gerber J.
Cruser D.
Kassaye S.G.
Mosnaim G.S.
Patel B.
Metcalf R.A.
Anjan S.
Reisler R.B.
Yarava A.
Lane K.
McBee N.
Gawad A.
Raval J.S.
Zand M.
Abinante M.
Broderick P.B.
Casadevall A.
Sullivan D.
Gebo K.A.
Publisher(s)
John Wiley and Sons Inc
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.
Start page
933
End page
941
Volume
62
Issue
5
Language
English
OCDE Knowledge area
Virología Enfermedades infecciosas Sistema respiratorio
Scopus EID
2-s2.0-85127372020
PubMed ID
Source
Transfusion
ISSN of the container
00411132
Sponsor(s)
The authors gratefully acknowledge the passionate, brave staff who participated in the CSSC‐001 and ‐004 trials as well as the study participants who generously gave of their time and biological specimens. Initial work was catalyzed by grants from Bloomberg Philanthropies and the State of Maryland. This study was funded principally by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO‐CBRND), in collaboration with the Defense Health Agency (DHA) (contract number: W911QY2090012) with additional support from Bloomberg Philanthropies, State of Maryland, the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID)3R01AI152078‐01S1, NIH National Center for Advancing Translational Sciences (NCATS) U24TR001609‐S3, Division of Intramural Research NIAID NIH, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation and the Shear Family Foundation. Dr. Bloch is supported in part by 1K23HL151826 (National Heart, Lung, and Blood Institute). The study sponsors did not contribute to the study design, the collection, analysis, and interpretation of data, and the decision to submit the paper for publication. Funding information.
Sources of information: Directorio de Producción Científica Scopus