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FDA Facilitating Expedition of Experimental Plasma Treatment in Serious COVID-19 Cases
The convalescent plasma may contain antibodies to the virus that causes COVID-19 that will make it easier for infected patients to recover.
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The US Food and Drug Administration (FDA) announced that they will make it easier for physicians to try convalescent plasma to treat patients with serious or life-threatening coronavirus disease 2019 (COVID-19) infection.
The convalescent plasma will be taken from recovered COVID-19 patients in the hopes that it may contain antibodies to SARS-CoV-2 (the virus that causes COVID-19) that will make it easier for newly infected patients to recover.
“Given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is 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 under 21 CFR 312.310,” the FDA stated in the guidance to physicians released March 24, 2020.
The use of convalescent plasma has been studied in other respiratory disease outbreaks including the 2009-2010 H1N1 influenza epidemic, the 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic.
The FDA stressed, however, that because the use of convalescent plasma has not been shown effective in every disease studied, it is critical to determine its safety for COVID-19 treatment through clinical trials before administrating it to patients.
Physicians will need to receive approval from the FDA for individual patient use, but in the event of an emergency that requires a response in <4 hours, they can contact the FDA’s Office of Emergency Operations (1-866-300-4374) to get verbal authorization.
The convalescent plasma must only be collected from recovered patients if they are eligible to donate blood, have a prior COVID-19 diagnosis documented by a laboratory test, and have complete symptom resolution at least 14 days before donating blood.
Patient are eligible to receive convalescent plasma if they have laboratory confirmed COVID-19, have severe or immediately life-threatening COVID-19, and provided informed consent.
The FDA is continuing to work with other governmental agencies including the National Institutes of Health and the Centers for Disease Control and Prevention to develop master protocols for the collection and use of convalescent plasma for COVID-19.
For more coronavirus coverage, visit our COVID-19 Resource Page.
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