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Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.
On March 24, 2020 FDA posted information about use of COVID-19 convalescent plasma as an investigational treatment for COVID-19. The agency said that while clinical trials are crucial before routine administration of such treatments, it is also facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for individual patients.
Convalescent plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) might possibly be effective against the infection. “Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2009-2010 H1N1 influenza virus pandemic, 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic. Although promising, convalescent plasma has not been shown to be effective in every disease studied,” said FDA. The agency encouraged investigators wishing to study the use of convalescent plasma to submit requests to FDA for investigational use under the traditional IND regulatory pathway.
In addition to these clinical trials, FDA is facilitating access for individual patients through eINDs, which allow the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization. FDA said this does not include the use of COVID-19 convalescent plasma for the prevention of infection. The agency provided information for healthcare providers interested in the emergency use of investigational COVID-19 convalescent plasma under a single patient eIND, noting considerations for donor eligibility and patient eligibility, as well as instructions on how physicians can submit requests. The agency said that the container label of COVID-19 convalescent plasma units must include the statement: “Caution: New Drug--Limited by Federal (or United States) law to investigational use."
FDA said it continues to work with the National Institutes of Health and the Centers for Disease Control and Prevention to develop master protocols for use by multiple investigators in order to coordinate the collection and use of COVID-19 convalescent plasma.
FDA also posted a frequently asked questions page on March 26, 2020, including information for physicians and potential donors.