The University of Arkansas for Medical Sciences, which has been organizing, with the Arkansas Department of Health and blood collectors, the donation of plasma from persons recovered from COVID-19 to patients hospitalized with the disease, has received Food and Drug Administration approval for “expanded access.” The authorization provides a blanket approval (rather than patient by patient) for the use of convalescent plasma to UAMS for Arkansas research statewide.
In a news release, Dr. Tina S. Ipe, associate professor and division director for UAMS Transfusion Medicine Services and project leader for the statewide convalescent plasma effort, said that had the university participated in a nationwide program, “much of what was donated here would have gone to hotspots elsewhere.”
The convalescent plasma is being donated to COVID-19 patients in the hope that antibodies in the plasma will reduce the effect of virus. So far, results have been encouraging. UAMS began collecting the plasma in early April; it was then required to go through the FDA approval process for each individual case. The first patient to receive convalescent plasma, Mirna Marquez, had been on a ventilator for 10 days, but was able to leave the hospital on April 20. At least four patients had been able to come off the ventilator after receiving the plasma, Ipe told the Times last week.
Hospitals across Arkansas are taking part in the UAMS Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program, a collaboration unique in UAMS-guided research. As of last week, 30 people had donated and 13 patients had received plasma, infectious disease Dr. Brandon Walser said Monday. Walser, who has provided convalescent plasma to his COVID-19 patients at Baptist Health, said Monday that he was “very encouraged with what I’ve seen in response to my patients. Those that have received the serum have done generally well.”
Baptist Health North Little Rock Chief Medical Officer Dr. Stan Kellar is coordinating the identification of patients within the Baptist system who have tested positive, are recovered and are potential donors. “I would say a full 90 percent of those who I’ve contacted are anxious to participate,” Kellar said.
The Arkansas Blood Institute, the Community Blood Center of the Ozarks in Northwest Arkansas and LifeShare in Southwest Arkansas are collecting blood for the project.
The expanded access program is not a double-blind study as is the case in a clinical trial. However, the FDA has approved the use of convalescent plasma because it seemed to help in the treatment of SARS, the coronavirus that spread in 2003, and MERS, a deadly coronavirus that rose in the Middle East in 2012.
In the press release announcing the expanded access program, Shuk-Mei Ho, UAMS vice chancellor for research and innovation, is quoted as saying the program was “only possible because of the hard work of many people who were able to get this approval in record time. Creating partnerships, writing protocols and getting FDA and IRB (Institutional Review Board) approval can usually take several months to half a year. Instead, our partners got this done in weeks, and the FDA approval came within days of submission. It’s unheard of.”
To donate, patients must have been asymptomatic for 15-28 days and be tested again for the virus to make sure none remains. After 28 days, no test is required. They will be screened by the blood collector for other impediments to collection. At the COVID-19 press briefing Wednesday, Secretary of Health Dr. Nate Smith said 2,109 patients have recovered from the illness. Active cases totaled 1,374.
The Centers for Disease Control and Prevention has more information on convalescent plasma. Health care providers interested in using COVID-19 convalescent plasma through the expanded access program are asked to contact Ipe at TIpe@uams.edu.