WVU Medicine receives FDA Investigational Drug Approval for COVID-19 immunotherapy

MORGANTOWN, W.Va. – WVU Medicine pediatric and adult allergist and immunologist Brian Peppers, D.O., Ph.D., has received Investigational New Drug approval from the U.S. Food and Drug Administration for the experimental treatment of COVID-19 using convalescent donor plasma. This is the first FDA approved Investigational New Drug trial for COVID-19 immunotherapy to include pediatric patients.

Brian Peppers, D.O., Ph.D.
Brian Peppers, D.O., Ph.D.

The protocol, titled “Convalescent plasma collection from individuals that recovered from COVID-19 and treatment of critically ill individuals with donor convalescent plasma,” will use convalescent donor plasma to deliver COVID-19 antibodies to patients currently fighting the disease.  

Convalescent donor plasma is collected from someone who has been infected by COVID-19 and has recovered from the infection. The plasma contains antibodies which identify the virus and stimulate the immune system to remove it. 

This technique is the basis for immunotherapy, using the body’s own immune system to fight an illness. Convalescent plasma has been used to promote heath and healing in those suffering from Ebola, MERS, H1N1, and bird influenza. This therapy has been used successfully for nearly 100 years and offers an approach to treatment while vaccines and other forms of treatments are developed.

“The aim of this study as well as the others that involve only adults is to determine if it will help promote health for those with this specific infection,” Dr. Peppers said. “Similar pilot studies for the treatment of COVID-19 have shown positive results.”

The long-term goal of the study is to develop an enriched and purified antibody medication.  Antibody therapies, such as immunoglobulin G (IgG), already exist for other infections such as hepatitis B and varicella. 

“It takes a village to conduct research of this kind,” Peppers said. “The creation of this study and the speed of it getting to the FDA would not have been possible without the aid of the co-investigators on the study, Lisa Giblin Sutton, Pharm.D., Aaron Shmookler, M.D., Pete Perrotta, M.D., Sunil Sharma, M.D., and David Skoner, M.D., and the efficiency of WVU’s Institutional Review Board during these times.”

The WVU Medicine protocol has the ability to use larger doses of donor plasma than the national campaign in the hopes of stimulating the immune system and eradicate the virus in severe and critically ill patients. Both adult and pediatric patients are eligible for this protocol.

“While this technique has been used in the treatment of COVID-19, we are still working to identify the optimal therapeutic dose and at what stage of the illness the treatment is most effective,” Peppers said.