A monoclonal antibody, now moving through clinical trials that were designed in part by UNC scientists, has been found to significantly — and at a scope that surprised researchers — reduce the risk of contracting COVID-19 among residents and staff of long-term care facilities.
Pharmaceutical maker Eli Lilly released results last week of a trial that exceeded what researchers expected in the magnitude of treatment and prevention benefits realized by residents of skilled nursing facilities.
The antibody is called bamlanivimab, and the Phase 3 trial was conducted in partnership with the NIH’s National Institute of Allergy and Infectious Diseases and the COVID-19 Prevention Network. Dr. Myron Cohen, director of UNC’s Institute for Global Health and Infectious Diseases and co-principal investigator of the network, helped to design and oversee the trial. Dr. David Wohl, UNC professor of infectious diseases, served as the UNC site principal investigator, working with several skilled nursing facilities in North Carolina.
Monoclonal antibodies are human-made proteins that act like human antibodies in the immune system. Earlier studies had found that bamlanivimab showed promise in treating COVID patients at risk of severe disease, earning an emergency use authorization from the Food and Drug Administration in November.
“The results of this innovative study further support the belief that bamlanivimab — and potentially other monoclonal antibodies — can reduce symptoms and may even prevent COVID-19,” Cohen said. “The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devastating impact the virus has had in this vulnerable population and other high-risk patients.”
Beginning in August 2020, the study enrolled 340 long-term care residents and 757 staff. Initially, 132 tested positive for the SARS-CoV-2 virus. Of the remaining 965 participants, symptomatic COVID-19 infections were reduced by 57 percent.
The patient receives an infusion of the drug intravenously over the course of an hour.
Among residents, the infections were reduced by 80 percent. There were four deaths among the 965 patients, all of them in the placebo group. When the 132 who tested positive at the study’s beginning were included, there were another four deaths — again, only among patients who received placebo. All deaths were residents, not staff.
Lilly researchers, working with Cohen, devised an unusual strategy for reaching participants. They retrofitted a fleet of recreational vehicles to prepare the study drug, conduct lab work and pull trailers that could be used as on-site infusion clinics. When a nursing home or long-term care facility had an outbreak, researchers could dispatch an RV.
“Of course, I think the vaccines are more effective than prophylaxis and likely longer lasting,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer. “So [monoclonal antibodies] should not be seen in any way as competition to vaccines. It should be for when it’s too late, when there’s an outbreak and people are getting exposed and there’s not going to be time for a vaccine to work.”