A National Institutes of Health panel says there’s no evidence backing the use of convalescent plasma to treat coronavirus patients and says doctors should not treat it as a standard of care until more study has been done.
“There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19,” the panel of more than three dozen experts says in a statement posted on the NIH website Tuesday.
“Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19,” added the committee, which evaluates treatments for coronavirus.
“Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19. Members of the public and health care providers are encouraged to participate in these prospective clinical trials.”
Some background: Last week, the US Food and Drug Administration issued an emergency use authorization for convalescent plasma, and US President Donald Trump declared it a historic breakthrough at a news conference.
The timing raised suspicions the White House had pressured FDA -- something FDA commissioner Dr. Stephen Hahn denied several times.
But Hahn had also made misleading comments about the data supporting the use of convalescent plasma -- which is the antibody-rich serum taken from the blood of people who have recovered from an infection. The hope is infusing this plasma into new patients will kickstart their immune response. It’s a treatment that dates back more than 100 years and has never been used broadly.
The NIH panel, led by Dr. Clifford Lane, who heads research at the National Institute of Allergy and Infectious Diseases; Dr. Roy Gulick, chief of the Division of Infectious Diseases at Weill Medical College of Cornell University; and Dr. Henry Masur, chief of the Critical Care Medicine Department at NIH, said much more research is needed into whether the treatment works. Data published so far don’t really show whether it helps patients, they said.
“The long-term risks of treatment with COVID-19 convalescent plasma and whether its use attenuates the immune response to SARS-CoV-2, making patients more susceptible to reinfection, have not been evaluated,” the statement added.
Plus, different patients have differing levels of antibodies, so the treatment is highly variable.