Health
FDA allows COVID convalescent plasma to some outpatients
Both FDA on Tuesday Restrict and extend Emergency Use Authorization (EUA) For convalescent plasma as a treatment for COVID-19.
inside that Updated EUAAuthorities have restricted the use of high-titer COVID-19 convalescent plasma to immunocompromised patients, but said that “these patients may be treated in outpatient or inpatient settings.” (Previously promising treatment use approved For early treatment of the disease course of hospitalized COVID-19 patients. )
To inform their decision, the FDA reviewed multiple studies, including randomized trials in both inpatients and non-inpatients, and convalescent plasma transfusions in inpatient immunoqualified patients with COVID-19 were “clinical. It is unlikely to be related to profits. ” In the updated approval letter, Dr. Shaughnessy, Deputy Chief Scientist of the FDA.
“But the evidence is that COVID-19 convalescent plasma with a high titer of anti-SARS-CoV-2 antibody to treat COVID-19 in patients with immunosuppressive disease or undergoing immunosuppressive treatment. Supports the potential clinical benefits of blood transfusions, “added O’Shaughnessy.
Arturo Casadevall, MD, PhD of the Johns Hopkins Bloomberg School of Public Health in Baltimore praised the authorities’ decision, noting that most of the COVID-19-approved monoclonal antibodies are no longer effective against Omicron variants. Did.
“We lost most of the mAbs and the antivirals aren’t here yet,” he said. Today’s MedPage..
“The FDA has moved very rapidly accordingly,” he said in an email. “The availability of plasma in the outpatient space compensates for the loss of monoclonals and allows plasma to be used optimally-in the early stages of illness.”
On twitter, Casadevall-COVID-19 Convalescent Plasma Trialist Advocate an increase in its use -Proposed Recently reported The Johns Hopkins trial results may have influenced the FDA’s decision.
In a study of convalescent plasma (CSSC-004) limiting SARS-CoV-2-related complications by Casadevall et al., Outpatients with COVID-19 who received high-titer convalescent plasma within 9 days of symptoms. Onset that has been shown to reduce the risk of hospitalization by more than 50%. Of the more than 1,100 patients who participated in the study, 6.3% of patients receiving placebo required hospitalization compared to 2.9% of patients receiving convalescent plasma (relative risk 0.46,). P= 0.004). There were 3 deaths in the placebo group, but none in the convalescent plasma group.
“The EUA changes allow doctors and blood bankers to bring the system for plasma collection and testing back into operation. It was essentially down. It cares about the power. It means that you can use very high quality plasma without having to do it. ” “Once the immunosuppressive drug supply line has been reestablished and the ongoing work to define the effective titers of Omicron has been completed, additional changes to the EUA may be made to outpatient immunosuppressors. . “
The FDA said clinical evidence of convalescent plasma in immunosuppressed patients with COVID-19 remains limited and requires data from additional randomized trials.
Kristina Fiore contributed to the report of this story.
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