The U.S. Food & Drug Administration has given the greenlight to Trinity Health of New England to test the use of antibodies from patients who have recovered from the COVID-19 coronavirus to treat patients who are critically ill or on ventilator support.
The clinical trial, in which Johns Hopkins and the Mayo Clinic are also taking part, involves injecting blood from recovered patients — known as convalescent plasma — into those who are in much worse shape and may have few treatment options.
Johns Hopkins and the Mayo Clinic have received similar FDA approvals.
Though there have been some promising early results of the treatment in China, and researchers have previously studied its use in connection to other outbreaks of respiratory infections, such as SARS in 2003 and H1N1 in 2009 and 2010, the FDA still deems convalescent plasma to be an investigational treatment for COVID-19.
“Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” the FDA says on its website. “Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.”
“Thousands of people across the country are sick with COVID-19 and currently there are no
vaccines and or proven therapies to combat this novel coronavirus,” Dr. Danyal Ibrahim, Trinity Health of New England’s regional chief quality officer, said in a statement.
“However, plasma from recovered COVID-19 patients has the promise to be lifesaving, especially for the most critically ill,” Ibrahim continued.
