Aug. 25 (UPI) — Officials at University of Florida Health announced Tuesday that they enrolled the first two participants in a national study to assess whether convalescent blood plasma stops progression of COVID-19 from mild to severe illness.
The Clinical Trial of COVID-19 Convalescent Plasma of Outpatients will be conducted at 50 medical centers across the country and ultimately enroll 600 participants, with half receiving convalescent blood plasma and the other half receiving a placebo multivitamin in a saline solution, officials said.
“We are trying to see if the blood plasma gives these patients an edge in the outpatient environment,” Dr. Lisa H. Merck, vice chair of research in the UF College of Medicine’s department of emergency medicine, said in a statement.
“This is a study that could ultimately change how we treat this population of patients,” she said.
On Sunday, the U.S. Food and Drug Administration granted an emergency use authorization for convalescent plasma in patients hospitalized with COVID-19.
That decision does not have an impact on the current study, which will test the treatment in patients early in the course of illness who are discharged from emergency rooms, officials said.
Convalescent plasma is the yellowish liquid part of blood. It contains antibodies produced by the immune system that help fight off infection. These antibodies remain in the blood even after a person recovers.
Based on history with other virus outbreaks — Ebola and H1N1 flu, among others — researchers think convalescent plasma obtained from people who have recovered from COVID-19 might protect others from worsening illness.
The study focuses on the use of convalescent plasma, collected by blood banks, that has a high load of antibodies. It’s the first national randomized control trial, the gold standard of clinical research, to test convalescent plasma.
To be eligible for the study, which is being funded by the National Institutes of Health, participants must have a mild form of COVID-19 that does not require hospitalization, Merck said.
They also must have one of several risk factors that make them more susceptible to severe illness from the virus, including being over age 50 and having heart or lung disease or diabetes.
Study participants will be tracked for a month, although researchers are focused on the first two weeks, when the course of a patient’s illness begins to become more defined, officials said.