Four former Food and Drug Administration commissioners said Monday that convalescent plasma therapy has the potential to be the best treatment available for coronavirus patients.
“More work has yet to be done to demonstrate that such a therapy is safe and effective, but if so, it could help millions of patients with the novel coronavirus both here and abroad,” former Commissioners Mark McClellan, Margaret Hamburg, Robert Califf, and Scott Gottlieb wrote in the Washington Post.
Plasma therapy is an experimental treatment in which doctors take blood from a patient who has recovered from COVID-19 and whose body has antibodies that it created to fight the virus. Doctors then take the liquid part of the blood, called plasma, and transfuse it into the COVID-19 positive patient’s blood. Doctors have been using convalescent plasma transfusion to treat infectious diseases for more than 100 years. It has not yet been clinically proven to treat the coronavirus, but it is a safe procedure.
“But if this is going to work, we need to do it right,” the commissioners said. “We need a concerted effort to collect blood plasma, along with clinical trials to determine when its benefits outweigh the risks so we can treat the right people at the right time.”
Preliminary studies of plasma therapy’s effectiveness in treating COVID-19 are promising. A small study published in May in the American Journal of Pathology found that 9 out of 25 COVID-19 patients showed improvement after seven days of receiving the therapy, and 7 of the 9 patients were discharged from the hospital. By day 14, after receiving plasma transfusions, 19 patients’ conditions had improved, and an additional four patients were discharged.
The former commissioners are urging the federal government to launch larger studies and randomized clinical trials to determine how helpful the treatment is in speeding up recovery time and improving patient outcomes. Part of the federal government’s $13 billion initiative to develop treatments and vaccines, called Operation Warp Speed, includes a program specifically aimed at researching promising treatments. The commissioners point out, though, that only a “small fraction” of COVID-19 patients are able to participate in plasma trials.
“The nation continues to struggle with high rates of hospitalizations and tragic deaths,” they said. “While vaccine development continues, it’s important to advance every promising treatment option to improve the odds for those who become sick.”
Nearly 4.7 million coronavirus infections have been confirmed in the United States, and more than 155,000 people have died, according to Johns Hopkins University data.
