Convalescent Plasma and the US Expanded Access Program: A Personal Narrative.

Area of Science:

• Immunology
• Infectious Diseases
• Public Health

Background:

• The COVID-19 pandemic necessitated rapid development of treatment strategies.
• COVID-19 convalescent plasma (CCP) emerged as a potential therapeutic option.
• An FDA-authorized Expanded Access Program (EAP) facilitated widespread CCP use.

Purpose of the Study:

• To describe the establishment and outcomes of the Mayo Clinic-housed CCP EAP.
• To evaluate the safety and efficacy of CCP in a large, diverse patient population.
• To share lessons learned for future public health crises.

Main Methods:

• Analysis of clinical data from nearly 100,000 patients treated under the EAP.
• Safety assessments in initial cohorts of 5,000 and 20,000 recipients.
• Efficacy evaluation focusing on mortality reduction with early, high-titer CCP administration.

Main Results:

• CCP treatment was implemented across 2,200 US hospitals, serving a diverse patient demographic.
• Early safety signals were identified within weeks of program initiation.
• High-titer CCP administered early in hospitalization reduced mortality by up to 33%.

Conclusions:

• The CCP EAP demonstrated the feasibility and benefit of a large-scale, collaborative treatment effort.
• CCP, particularly high-titer plasma given early, proved effective in reducing COVID-19 mortality.
• The program provided valuable insights for managing future pandemics and therapeutic plasma use.