The National Institutes of Health COVID-19 Treatment Guidelines Panel members provide an insightful summary of the rationale and data behind the Emergency Use Authorization (EUA) for the use of convalescent plasma to treat coronavirus disease 2019 (COVID-19). The following are 10 key points to remember:

1. No Food and Drug Administration (FDA)-approved therapeutics exist for COVID-19. Some therapies, including the use of convalescent plasma, have EUA.
2. An EUA does not constitute drug approval by the FDA. An EUA facilitates the availability of unapproved uses of medical products during a public health emergency.
3. A strong scientific rationale and historical precedents exist for the use of concentrated virus-specific immunoglobulin preparations, which is an FDA approved therapy for post-exposure prophylaxis in the setting of hepatitis B, varicella, and rabies.
4. The effectiveness of convalescent plasma on the other hand is unclear, with the only randomized trial demonstrating efficacy conducted over 40 years ago in the treatment of Argentine hemorrhagic fever.
5. While convalescent plasma was first used in China, then around the world for the treatment of COVID-19, enrollment in trials has been slow.
6. Two retrospective studies conducted by both the FDA and Mayo Clinic supported the EUA for convalescent plasma, notably in nonintubated patients who received high-titer convalescent plasma early in the course of the disease.
7. Both studies had major limitations. The FDA study showed an overall difference in 7-day mortality between patients who received convalescent plasma compared to those who did not. The Mayo study did not have a nontreated comparator group and examined high versus low antibody titer plasma.
8. The Panel has determined the data are insufficient to recommend for or against convalescent plasma for treating COVID-19.
9. The tension between expanding availability of therapies through the EUA and expanded access programs and the need to assess the effectiveness of these therapies in controlled settings through randomized trials has been a major challenge.
10. Collaboration between industry, governmental agencies, academia, and the public is essential in coordinating a robust research response through the rapid development, deployment, and analysis of high-caliber randomized trials.

Clinical Topics: COVID-19 Hub, Prevention

Keywords: Coronavirus, COVID-19, Drug Approval, Immunoglobulins, Plasma, Post-Exposure Prophylaxis, Public Health, Primary Prevention, severe acute respiratory syndrome coronavirus 2, Treatment Outcome, United States Food and Drug Administration

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