Plasma Therapy, Given Emergency Approval by FDA to Treat COVID, Actually Harmed Patients

Research just released has cast doubt on whether plasma treatments can help seriously ill COVID-19 patients, suggesting that in fact they may produce "adverse" effects.

The results of the study come after the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) last month for convalescent plasma therapy to be used to treat the disease.

While most randomized controlled trials have shown negative results, uncontrolled studies had raised hopes that the antibody content in the plasma could help other patients.

The study, whose results were released this week, examined the efficacy of using plasma from people who had recovered from the disease to treat other COVID patients in the hope that it could prevent intubations and deaths.

The study, published in Nature Medicine, included treating 940 patients within 12 days of getting COVID respiratory symptoms, in 72 hospitals in Canada, the U.S. and Brazil.

However, it concluded that there were more negative outcomes, including intubation and death, among those receiving the convalescent plasma therapy than those receiving standard care for COVID-19.

Deaths among the groups were similar but plasma therapy patients often needed oxygen and experienced worsening respiratory failure.

"Patients in the convalescent plasma arm had more serious adverse events" than those getting standard care, by 33.4 percent versus 26.4 percent," the study found.

"It has been thought that the blood plasma of COVID-19 survivors would help those seriously ill from the virus but, unfortunately, it does not," said Dr. Donald Arnold, from McMaster University, in Hamilton, Canada, and one of the study's investigators, in a press release, reported by Canadian media.

He added that his team would warn against using convalescent plasma to treat COVID-19 hospitalized patients "unless they are in a closely monitored clinical trial."

The reason for the results is still not known, but one of the researchers, co-principal investigator Philippe Bégin, said it could be because the dysfunctional antibodies could compete with the patient's own antibodies and disrupt an immune response.

"This phenomenon has been observed previously in animal models and in human studies of HIV vaccines," Bégin said in the press release.

A panel convened by the National Institutes of Health (NIH) found there is not enough evidence showing that plasma treatment is safe and effective nor did it make any difference in the seven-day survival for patients, Healthline reported.

In a statement the NIH said no data from a "well-controlled, adequately powered randomized clinical trials" had showed "the efficacy and safety of convalescent plasma for the treatment of COVID-19."

Newsweek has contacted the FDA for comment.

ICU Covid nurse
A nurse at Three Rivers Asante Medical Center, Oregon after treating a patient in the COVID-19 Intensive Care Unit on September 9, 2021. A study has cast doubt on whether plasma treatments can help COVID patients. Nathan Howard/Getty