The Food and Drug Administration (FDA) has issued a guidance about the process healthcare providers and researchers should use to obtain the agency’s approval to administer or study convalescent plasma collected from individuals who have recovered from COVID-19, the agency said.
Researchers are investigating the use of convalescent plasma collected from individuals who have recovered from COVID-19 as a possible treatment for patients suffering from COVID-19. Convalescent plasma is being studied as a treatment because it contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19). Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic, the agency noted.
Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product. That means a healthcare provider must apply to the FDA to administer it to patients through one of three investigational pathways:
· The first pathway is through a clinical trial. Investigators who want to study the use of convalescent plasma in a clinical trial should submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312), the FDA said. CBER’s Office of Blood Research and Review is committed to engaging with sponsors and reviewing such requests expeditiously, the FDA said.
· The second is an expanded access pathway, or IND application. This application for expanded access is an alternative for the use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials.
· The third pathway is for a single patient, or an emergency IND. This is a process in which a physician requests permission to treat a single patient. “This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met,” the FDA said.
If their request is approved through one of the three pathways, healthcare providers or hospitals would obtain COVID-19 convalescent plasma from an FDA-registered blood establishment, the FDA said.
