Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study
In this article, experts from Mayo Clinic and the national blood banking community describe the cohort of approximately 100,000 patients enrolled in the United States Expanded Access Program (EAP) for convalescent plasma for the treatment of coronavirus disease 2019 (COVID-19). They report on the demographic, geographical and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma.
Mayo Clinic researchers and collaborators show the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to an experimental treatment is needed in response to an emerging infectious disease.
Highlights of the article:
- The Expanded Access Program (EAP) was initiated to provide broad access to COVID-19 convalescent plasma and to provide a framework for standardized collection of data describing the safety profile of convalescent plasma.
- The EAP provided rapid and broad access to convalescent plasma throughout the US and some US territories and was effective at providing therapy for demographic groups that were severely affected by COVID-19.
- In addition, the data provide evidence supporting that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.
- The study design of the EAP may serve as an example for future efforts in response to a rapidly developing infectious disease when broad access to an experimental treatment is needed in areas and demographic groups that are often underrepresented in clinical trials.
- The article includes a choropleth map displaying the number of cumulatively enrolled patients in the EAP within each state of the US and participating territories.