Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.
Level 4 - case-series / case-control
Uncontrolled single-arm registry study (Expanded Access Program) without a comparator group.
PubMed 34928960 · doi:10.1371/journal.pmed.1003872
What was done
Data were analyzed from the United States Expanded Access Program (EAP) national registry on hospitalized patients aged 18 years or older with, or at risk for, severe or life-threatening COVID-19 who received convalescent plasma between April 3 and August 23, 2020. The study tracked demographic characteristics, geographic and chronological enrollment relative to state infection rates, serious adverse event rates, and crude 30-day mortality across US hospital referral regions.
What was found
The registry enrolled 105,717 patients. Among participants, 57.8% were aged 60 years or older, 58.4% were male, 83.8% had overweight or obesity, 46.4% were of non-white race, and 37.2% were of Hispanic ethnicity. EAP enrollment and transfusions mirrored confirmed SARS-CoV-2 infection patterns across all 50 states, reaching metropolitan as well as non-metropolitan areas lacking clinical trials. Transfusion-related serious adverse events were reported in <1% of patients. Crude 30-day mortality was 25.2% (95% CI, 25.0% to 25.5%).
Why it matters
The findings show that an expanded access registry framework can rapidly scale to provide nationwide access to an investigational therapy, including substantial representation of racial and ethnic minority populations, with a low observed rate of serious transfusion reactions.
Limits
The study was purely observational and pragmatic with no control or comparator group, meaning therapeutic efficacy cannot be inferred from these data. Findings are vulnerable to confounding, variable clinical practice across participating sites, and potential underreporting of non-immediate adverse events.
Cited by
- supports The FDA granted emergency use authorization for convalescent plasma for COVID-19 based on studies that lacked control groups.