Plasma therapy, FDA approved for emergency treatment of COVID, actually injured patients

The newly published research has cast doubt on whether plasma treatments can help critically ill COVID-19 patients, suggesting that they may in fact produce “negative” effects.

The study results come after the Food and Drug Administration (FDA) last month issued an Emergency Use Clearance (EUA) 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 plasma might help other patients.

The study, the results of which were published this week, looked at the effectiveness 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 Natural medicine, included the treatment of 940 patients within 12 days of onset of respiratory symptoms of COVID, at 72 hospitals in Canada, the United States and Brazil.

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

Deaths among the groups were similar, but patients on plasma therapy often required oxygen and had worsening respiratory failure.

“Patients in the convalescent plasma arm had more serious adverse events” than those receiving standard care, 33.4% versus 26.4%, “the study found.

“It was thought that the blood plasma of COVID-19 survivors would help those seriously ill with the virus but, unfortunately, it does not,” said Dr Donald Arnold, of McMaster University in Hamilton, in 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 hospitalized COVID-19 patients “unless they are participating 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 already been observed in animal models and in human studies of HIV vaccines,” Bégin said in the press release.

A group of experts convened by the National Institutes of Health (NIH) found that there was insufficient evidence to show that plasma treatment was safe and effective and that it made no difference in survival. to seven days of patients, Healthline reported.

In a statement, the NIH said that no data from “well-controlled and sufficiently powerful randomized clinical trials” had shown “the effectiveness and safety of convalescent plasma for the treatment of COVID-19.”

News week has contacted the FDA for comment.