Based on its own review of data on use of convalescent plasma to treat COVID-19, NIH finds insufficient data to recommend for or against its use, the statement says.
On August 23, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)* for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.
In a statement issued on September 1, 2020, the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel (the Panel) announced results of its own review of currently available evidence on use of convalescent plasma for treatment of COVID-19 infection, including the analyses used by FDA in support of the EUA. Here are results of that review.
Impression: There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.
FDA analysis. FDA analyzed data on a subset of hospitalized patients from the Mayo Clinic’s Expanded Access Program (EAP) that compared outcomes in patients who received convalescent plasma with high titers of SARS-CoV2 neutralizing antibodies to outcomes in patients who received plasma with low titers and found:
Although it appears based on these data that convalescent plasma with high antibody titers may be beneficial in nonintubated patients, there is uncertainty about the safety and efficacy of convalescent plasma for several reasons:
NIH COVID-19 Treatment Guidelines, Convalescent Plasma ___________________________________________________________________________
Globally, as of September 1, 2020, there have been 25 511 385 confirmed cases of COVID-19, 851 352 deaths, and 16 863 597 recoveries.