The University of Arkansas for Medical Sciences (UAMS) has received authorization to use convalescent plasma as an experimental treatment for COVID-19 patients in Arkansas.
The Food and Drug Administration (FDA) authorized the use of the experimental treatment, with UAMS serving as the expanded access treatment program sponsor. Under the terms of the authorization, UAMS can treat patient with convalescent plasma without applying to the FDA for every patient. In addition, other Arkansas health care providers can utilize the treatment through the UAMS Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program.
“This ensures that convalescent plasma collected in Arkansas will benefit Arkansas patients,” Tina S. Ipe, M.D., M.P.H., associate professor and division director for UAMS Transfusion Medicine Services, said in a statement. “If we had simply participated in an established nationwide program, much of what was donated here would have gone to hotspots elsewhere. The creation of this program gives us the chance to explore this potential treatment in Arkansas, for Arkansans.”
Ipe will be serving as the project leader for the statewide convalescent plasma effort.
Convalescent plasma is collected from individuals who have been infected and recovered from COVID-19. Plasma can contain antibodies to fight viruses, and health officials are hoping that COVID-19 convalescent plasma will fight the virus.
Using convalescent plasma is currently an unproven treatment. According to the FDA, convalescent plasma has “not yet been shown to be safe and effective as a treatment for COVID-19.
In a set of guidance release May 1, the FDA announced that administering convalescent plasma must take place under specific circumstances. These circumstances include an investigation new drug application (IND) under the traditional IND regulator pathway, an expanded access IND, or a single-patient emergency investigational new drug application.
Hospitals must collect COVID-19 convalescent plasma from individuals who meet specific guidelines. The FDA lists this guidelines as providing evidence of COVID-19 via a laboratory test, complete resolution of symptoms at least 14 days before the donation, and additional tests for antibodies.