The FDA allows COVID convalescent plasma for some outpatients

The FDA on Tuesday both restricted and extended the emergency use permit (EUA) for convalescent plasma as a treatment for COVID-19.

In its updated EUA, the Agency restricted the use of high titer covid-19 convalescent plasma to immunocompromised patients, but stated that “these patients can be treated in an outpatient or inpatient setting.” (Previously, the use of the once promising therapy allowed the treatment of any hospitalized COVID-19 patient early in the course of their disease.)

To inform about their decision, the FDA reviewed several studies, including randomized trials in both hospitalized and non-hospitalized patients, and found that convalescent plasma transfusion in hospitalized immunocompetent patients with COVID-19 is “unlikely to be associated with clinical benefit,” Jacqueline wrote. O ‘Shaughnessy, PhD, FDA Acting Chief Researcher, in the updated approval letter.

“However, evidence supports a potential clinical benefit of transfusing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies to treat COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive therapy,” O’Shaughnessy added.

Arturo Casadevall, MD, PhD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, praised the agency’s decision, noting that most of the monoclonal antibodies approved for COVID-19 are no longer effective against the Omicron variant.

“We’ve lost most of the mAbs, and the antiviral pills are not here yet,” he said MedPage today.

“The FDA has moved very quickly in response,” he said via email. “The availability of plasma in the outpatient setting compensates for the loss of monoclonal cells and allows plasma to be used in an optimal way – early in the disease.”

On Twitter, Casadevall – a COVID-19 convalescent plasma experimenter who has advocated for its increased use – suggested that recently reported test results from Johns Hopkins may have informed the FDA’s decision.

The convalescent plasma to limit the SARS-CoV-2 Associated Complications (CSSC-004) trial from Casadevall and colleagues showed a greater than 50% reduction in hospitalization risk for outpatients with COVID-19 who received high-titer convalescent plasma within 9 days after symptom onset. Among more than 1,100 patients in the study, 6.3% of those receiving placebo required hospitalization, compared with 2.9% of those receiving convalescent plasma (relative risk 0.46, P= 0.004). There were three deaths in the placebo arm versus none in the convalescent plasma arm.

“The change in the EUA allows doctors and blood bankers to put the plasma collection and testing system back into operation, which had essentially stalled. This means that very high quality plasma will be available without any worries about titer,” Casadevall tweeted. “Once the supply line is re-established for the immunosuppressed and the ongoing work to define effective titer for omicron is complete, we will see further changes to the EUA that may be extended to include outpatient immunocompetent.”

The FDA noted that the clinical evidence for convalescent plasma in immunosuppressed patients with COVID-19 remains limited and data from further randomized trials are needed.

Kristina Fiore contributed reporting to this story.

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    Ian Ingram is the Editor-in-Chief of MedPage Today and helps cover oncology for the site.

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