Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study
PLoS Medicine — Senefeld JW, Johnson PW, Kunze KL, et al. | January 11, 2022
In response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, initiation of the United States (US) Expanded Access Program (EAP) to COVID-19 convalescent plasma was done with the aim to provide broad access to COVID-19 convalescent plasma and to present a framework for standardized collection of data defining the safety profile of convalescent plasma. In this study, the demographic, geographical, and chronological characteristics of patients in the EAP are described and key safety metrics following transfusion of COVID-19 convalescent plasma are reported.
For all participating facilities, Mayo Clinic served as the central institutional review board, and US physicians herein participated as local physician–principal investigator.
A total of 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP from April 3 to August 23, 2020.
Patients, in majority, were 60 years of age or older (57.8%), were male (58.4%), and were overweight or obese (83.8%).
Throughout the US and some US territories, rapid and broad access to convalescent plasma was achieved because of the EAP.
EAP was identified as effective in aiding the provision of therapy for demographic groups that were severely affected by COVID-19.
Further, the data yielded evidence supporting the safety of performing transfusion of convalescent plasma in hospitalized patients with COVID-19.
The study design of the EAP may yield guidance for future efforts in response to a rapidly spreading infectious disease when broad access to a treatment is required in areas and demographic groups that are frequently poorly represented in clinical trials.
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