Home In Reply — Limitations of Safety Update on Convalescent Plasma Transfusion in COVID-19 Patients This letter to the editors of Mayo Clinic Proceedings continues an ongoing scholarly conversation around the article "Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients." The authors recognize the points raised in the preceding letter as crucial future steps in establishing the clinical efficacy of COVID-19 convalescent plasma as a therapeutic agent. Main points include: The primary purpose of the "Safety Update" article was to provide descriptive data on key safety metrics after transfusion of COVID-19 convalescent plasma in a specific cohort of critically ill patients. Exploratory analyses of efficacy were beyond the scope of the article but are justified and forthcoming. The U.S. COVID Plasma Expanded Access Program (EAP) was a pragmatic study design, organized to allow routine clinical care to dictate the timing and administration of plasma with the collection of real-world data. Further discussion is merited regarding the evolution of the EAP, including the logistic issues associated with conducting a randomized controlled trial on convalescent plasma — rather than or in addition to a pragmatic study design — during the COVID-19 pandemic. Read the letter.
This letter to the editors of Mayo Clinic Proceedings continues an ongoing scholarly conversation around the article "Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients." The authors recognize the points raised in the preceding letter as crucial future steps in establishing the clinical efficacy of COVID-19 convalescent plasma as a therapeutic agent. Main points include: The primary purpose of the "Safety Update" article was to provide descriptive data on key safety metrics after transfusion of COVID-19 convalescent plasma in a specific cohort of critically ill patients. Exploratory analyses of efficacy were beyond the scope of the article but are justified and forthcoming. The U.S. COVID Plasma Expanded Access Program (EAP) was a pragmatic study design, organized to allow routine clinical care to dictate the timing and administration of plasma with the collection of real-world data. Further discussion is merited regarding the evolution of the EAP, including the logistic issues associated with conducting a randomized controlled trial on convalescent plasma — rather than or in addition to a pragmatic study design — during the COVID-19 pandemic. Read the letter.