The Food and Drug Administration (FDA) has launched a new webpage with information for recovered individuals who were infected with coronavirus disease 2019 (COVID-19) on where they can go to donate plasma to aid in the treatment of severely ill patients.
The use of convalescent plasma has been investigated before during other respiratory infection outbreaks, such as the 2009-2010 H1N1 influenza virus pandemic and the 2003 SARS-CoV-1 epidemic. Limited data from China have shown that this approach may potentially improve clinical symptoms in the most severe cases of COVID-19.
Convalescent plasma therapy for COVID-19 is currently being investigated across the nation by more than 1040 sites and 950 physicians through an expanded access program led by the Mayo Clinic. In addition, several clinical trials are evaluating the safety and efficacy of the therapy. The Agency is also accepting single-patient emergency Investigational New Drug Applications for individual patients.
In order to be eligible for donation, individuals will need to have had a prior laboratory-documented diagnosis of COVID-19 and must have complete resolution of symptoms for at least 28 days before they donate. Alternatively, patients who have no symptoms for at least 14 days prior to donation and have a negative lab test for active COVID-19 disease are also eligible.
“Those individuals who have recovered from COVID-19 could have an immediate impact in helping others who are severely ill,” said FDA Commissioner Stephen M. Hahn MD in a press statement. “In fact, 1 donation has the potential to help up to 4 patients.” Convalescent plasma can also be used to manufacture hyperimmune globulin, which can be used to treat patients with COVID-19, Hahn added.
Sites for plasma donation are being coordinated between the FDA and the American Red Cross.
For more information visit redcrossblood.org.