The FDA has permitted emergency use authorization for convalescent plasma as a treatment for severe COVID-19. The FDA has recommended that the plasma be tested for the presence of antibodies against the COVID-19 virus. However, each unit of donated plasma may contain a different level of antibody, some with high concentrations of antibodies and others with lower concentrations. The extent to which antibody levels in convalescent plasma translate to clinical outcomes has not been tested in a randomized control trial.
Led by Luther Bartelt, MD, assistant professor of infectious diseases, researchers are working to determine if a higher titer of neutralizing antibodies is safe and more effective. One group of patients will receive plasma that meets a validated minimum titer of neutralizing antibody; a second group will receive plasma with even higher neutralizing antibody titer.
This trial is for hospitalized patients. To donate plasma to help this trial, visit UNC Research for Me.
“Our trial is opening at a time when we clearly need answers to whether or not COVID-19 convalescent plasma with validated anti-viral activity is clinically beneficial for patients hospitalized with COVID-19,” Bartelt says. “CoVIP is a 100 percent UNC-initiated collective effort that is only possible through the diverse talents, determination, and collaborations of so many collaborators across campus.” Collaborators include researchers, doctors, nurses, and staff at the Department of Medicine, the Clinical Trials Unit, the UNC Respiratory Diagnostic Center, the UNC Blood Bank, several COVID-19 basic science labs, the SOM/UNC Health Foundation, the NC Policy Collaboratory, and other departments and areas at UNC-Chapel Hill.
“We’re especially grateful for the many COVID-recovered donors, each one a volunteer and many on a repeat basis, who provided their plasma for use in this trial,” Bartelt says.
Since the spring, UNC has been part of the Mayo Clinic convalescent plasma therapy program, authorized by the FDA under its expanded access program. UNC doctors, who have been using convalescent plasma as a treatment at the UNC Medical Center, will now transition their use of convalescent plasma to the CoVIP double-blinded research clinical trial.
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