Senefeld JW, Johnson PW, Kunze KL, et al. - In response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the Expanded Access Program (EAP) was initiated in the United States with the aim 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. 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.

• The EAP central website was employed to enroll eligible patients.

• Rapid implementation of programs was done by blood collection facilities to collect convalescent plasma for hospitalized patients with COVID-19.

• From April 3 to August 23, 2020, the EAP had enrollment of 105,717 hospitalized patients with severe or life-threatening COVID-19.

• Patients, in majority, were 60 years of age or older (57.8%), were male (58.4%), and were overweight or obese (83.8%).

• Minorities and underserved populations were included substantially: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity.

• As per observations, implementation of the EAP resulted in rapid and broad access to convalescent plasma throughout the US and some US territories; the program was identified as effective at providing therapy for demographic groups that were severely affected by COVID-19.

• This study yielded evidence supporting the safety of transfusing convalescent plasma in hospitalized patients with COVID-19.

• The study design of the EAP may serve as an example for future efforts when broad access to a treatment is required in response to an emerging infectious disease.