Program and patient characteristics for the United States Expanded Access Program to COVID-19 convalescent plasma

Area of Science:

• Immunology
• Infectious Diseases
• Public Health

Background:

• The COVID-19 pandemic necessitated rapid therapeutic interventions, including convalescent plasma.
• Vulnerable racial and ethnic minority populations were disproportionately affected, requiring equitable treatment access.
• The US Expanded Access Program (EAP) was established to provide timely access to COVID-19 convalescent plasma.

Approach:

• A nationwide EAP was implemented, coordinated by Mayo Clinic as the central Institutional Review Board.
• Physicians registered patients via a central website, and blood banks developed logistics for plasma distribution.
• Demographic, geographic, and chronological data on patient enrollment were collected and analyzed.

Key Points:

• Over 105,000 hospitalized patients with severe COVID-19 received convalescent plasma between April and August 2020.
• The program enrolled a substantial proportion of minority (46.4%) and Hispanic (37.2%) patients.
• Enrollment geographically spanned all US hospital referral regions, including metropolitan and less populated areas.
• Patient enrollment trends closely mirrored state-level infection rates, demonstrating responsiveness.

Conclusions:

• The EAP successfully facilitated broad and equitable access to COVID-19 convalescent plasma across all 50 states.
• The program's design ensured inclusion of underserved populations historically underrepresented in clinical studies.
• The EAP model offers a valuable framework for future public health emergencies requiring rapid, widespread treatment access.