Investigational COVID-19 Convalescent Plasma – Emergency INDs

One investigational treatment being explored for COVID-19 involves the use of convalescent plasma collected from recovered COVID-19 patients. 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. 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. It is therefore important to determine through clinical trials, before routinely administering convalescent plasma to patients with COVID-19, that it is safe and effective to do so. Investigators wishing to study the use of convalescent plasma are encouraged to submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR 312). You will have to log in or register to view the full content.  

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