FDA facilitating compassionate use of convalescent plasma for COVID-19
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FDA Tuesday released guidance to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis, outside of a clinical trial.
The presidents of the U.S. National Academy of Sciences, National Academy of Medicine, and National Academy of Engineering signed a statement on March 23 expressing strong support for “taking steps necessary to assess the potential for human convalescent plasma to help control COVID-19.” The statement characterizes convalescent plasma as “highly promising” and notes that it is a “tried-and-true treatment found effective in treating infections.” It encourages academia, industry and the federal government to collaborate to expedite the investigation and regulatory approval of convalescent plasma.
FDA stated that while it “is possible that convalescent plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) might be effective against the infection,” the safety and effectiveness of the practice have not been established in clinical trials.
Convalescent plasma has been used to treat a number of respiratory outbreaks. “Although promising, convalescent plasma has not been shown to be effective in every disease studied,” FDA noted.
Because patients may not have access to a clinical trial, FDA said it “is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections” via single patient emergency Investigational New Drug Applications (eINDs).
FDA provided criteria for convalescent plasma donors, including both a prior diagnosis of COVID-19 from a laboratory test and a negative test indicating that the donor has recovered. It also specified a test documenting the presence of “defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., optimally greater than 1:320).”
The agency outlined steps for physicians to seek authorization within four to eight hours, or in an emergency, to obtain immediate verbal authorization by telephone.
Physicians and scientists from over 20 institutions have formed a group, the COVID-1- Convalescent Plasma Project (CCPP19) to deploy the therapy. CCPP19 has made draft protocols available for physicians and hospitals, and is coordinating the collection of outcomes data.
The European Blood Alliance, an association of not for profit blood establishments, has started a study group to share protocols and information about convalescent plasma.
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