Using ‘Ancient History’: FDA Says Study Will Offer Plasma Therapy For COVID-19

The Food and Drug Administration on Friday announced a national study led by the Mayo Clinic that will help hospitals offer an experimental plasma therapy for COVID-19 patients, and track how they fare.

The therapeutic agents—convalescent plasma and hyperimmune globulin—are both derived from the blood of people who have recovered from the disease.

“This is an important area of research—the use of products made from a recovered patient’s blood to potentially treat” the fast-spreading disease caused by the coronavirus that has become a global pandemic, FDA Commissioner Stephen Hahn said in a release announcing the trials.

Dr. David Reich, president of New York’s Mount Sinai Hospital, hailed the “call to action.”

“People feel very helpless in the face of this disease. And this is one thing that people can do to help their fellow human beings,” he said.

As treatments get underway, “we just hope it works,” he added.

What the history books call “convalescent serum” was most famously used during the 1918 flu pandemic, and also against measles, bacterial pneumonia and numerous other infections before modern medicine came along.

It works because when infection strikes, the body starts making proteins called antibodies specially designed to target that germ. And those antibodies float in survivors’ blood — specifically plasma, the yellowish liquid part of blood — for months, even years.

“This seems like ancient history, but maybe it isn’t. There have been niche uses of it for a while,” Michael Joyner, a physiologist at the Mayo Clinic who in March spearheaded the creation of an ad hoc coalition of researchers interested in pursuing the therapy, told Wired.

Joyner is facilitating the 40-center trial of the new therapies approved by the FDA, with researchers at Johns Hopkins leading the science, Wired reported.

Some hospitals are already administering convalescent plasma to critical COVID-19 patients, a so-called “compassionate use” that in this case is allowed by what the FDA calls an emergency Investigational New Drug authorization.

At Houston Methodist Hospital, James Musser, the chair of Pathology and Genome Medicine, is a friend of Arturo Casadevall, the Johns Hopkins University immunologist who proposed using convalescent serum early in the pandemic, Wired reported.

Musser pushed to get his hospital involved.

“So far, as of yesterday, we’ve transfused four patients,” Musser said on Thursday. He expected a fifth to receive plasma Friday. But it’s too early to say it worked, he told Wire.

“We, nationally, need to do controlled trials and understand, first and foremost, is this a safe therapeutic? There’s lots of reasons to think it will be, but you never know,” he told the news outlet.

The Associated Press contributed to this report.

via newsmax

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