Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients

Area of Science:

• Infectious Diseases
• Hematology
• Critical Care Medicine

Background:

• Previous studies demonstrated the safety of convalescent plasma transfusion in 5,000 hospitalized coronavirus 2019 (COVID-19) patients.
• The US Food and Drug Administration's Expanded Access Program facilitated broader access to this therapy.

Purpose of the Study:

• To update key safety metrics for convalescent plasma transfusion in hospitalized COVID-19 patients.
• To assess the safety and potential impact on mortality of convalescent plasma in a larger cohort.

Main Methods:

• A convenience sample of 20,000 hospitalized COVID-19 patients received convalescent plasma.
• Data collected from April 3 to June 2, 2020, under the FDA Expanded Access Program.
• Analysis focused on serious adverse events, including transfusion reactions, thromboembolic events, and cardiac events, as well as 7-day mortality rates.

Main Results:

• The incidence of serious adverse events was low: transfusion reactions (<1%), thromboembolic events (<1%), and cardiac events (~3%).
• Most thromboembolic/cardiac events were deemed unrelated to plasma transfusion.
• The 7-day mortality rate was 13.0%, with higher rates in critically ill patients (ICU admission, mechanical ventilation, septic shock).

Conclusions:

• Transfusion of convalescent plasma is safe in hospitalized COVID-19 patients.
• Earlier administration of convalescent plasma may be associated with reduced mortality.
• These findings support the continued use and investigation of convalescent plasma therapy for COVID-19.