FDA Grants First Approval of Convalescent Plasma Therapy in COVID-19 Patient
Houston Methodist first to receive eIND approval for convalescent plasma in individual patient
TUESDAY, March 31, 2020 (HealthDay News) -- Over the weekend, the U.S. Food and Drug Administration granted the first approval for an academic medical center to transfuse donated plasma from a recovered novel coronavirus (COVID-19) patient into a critically ill patient.
On March 24, the FDA announced that while clinical trials are being conducted on the use of convalescent plasma for COVID-19 treatment, the agency is accepting single-patient emergency Investigational New Drug Applications for Individual patients, allowing a licensed physician to use an investigational drug to treat an individual patient with a serious or life-threatening infection. The FDA provided guidelines for donor eligibility, including complete resolution of symptoms for at least 14 days prior to donation and negative COVID-19 results from one or more nasopharyngeal swab specimen or a molecular diagnostic blood test.
The agency fast-tracked this approval for Houston Methodist, where physicians started recruiting blood plasma donors on Friday. About 250 patients have tested positive for COVID-19 at Houston Methodist hospitals. Willing donors each provided a quart of blood plasma. The first donor was a COVID-19 patient who had been "in good health" for more than two weeks; the plasma from this patient was transfused into a COVID-19 patient on Saturday night at Houston Methodist Hospital.
COVID-19 patient chart review revealed that nearly two-thirds of the COVID-19 patients at Houston Methodist hospitals meet the criteria to donate blood plasma, according to Eric Salazar, M.D., Ph.D., of Houston Methodist Hospital and Research Institute. Noneligible donors include those with critical underlying conditions and older age.