FDA nears decision authorizing COVID-19 treatment with convalescent plasma

Sources familiar with the issue say FDA may soon make a decision to authorize emergency use of blood plasma from recovered COVID-19 patients for treating those infected with the disease. Some physicians and hospitals already treat hospitalized COVID-19 patients with convalescent plasma under compassionate use and as part of studies. An expanded-access program sponsored by FDA and supervised by the Rochester, MN-based Mayo Clinic has allowed more than 48,000 COVID-19 patients receive convalescent plasma. The program is also examining the treatment’s safety. If FDA implements an emergency-use authorization, hospitals could access the therapy more easily. Initial studies suggest that convalescent plasma is generally safe to use and enhances the survival of hospitalized patients. Researchers at the University of Pittsburgh, Michigan Medicine, Medical University of South Carolina, and Stanford Medicine said this week they received federal funds for a 600-subject study that will in part examine the use of convalescent plasma in patients just starting to show symptoms.