Researchers from the University of Louisville are working with Eli Lilly and Company in a clinical trial to determine whether its monoclonal antibody treatment, bamlanivimab, can reduce the risk of transmission of COVID-19 in long-term care facilities.
The Phase 3 trial enrolls residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who now are at a high risk of exposure. The study, which included Essex Nursing and Rehabilitation Center in Louisville recently, is to evaluate the efficacy and safety of bamlanivimab for the prevention of COVID-19. The study also is exploring treatment of recently diagnosed SARS-CoV-2- and COVID-positive patients who are at high-risk of developing severe disease.
As the only Kentucky location for the Phase 3 clinical trial, UofL’s Division of Infectious Diseases worked with mobile units deployed by Lilly to the Louisville site to enroll and treat trial participants. Julio Ramirez, director of the division, leads the work, which includes follow-up monitoring for study participants at this facility and any others in Kentucky who may participate in the trial.
“We are thrilled to be partnering with NIH and Lilly for the implementation of their BLAZE-2 study in Kentucky. With nearly 30,000 residents in long-term care facilities in the state, there is an urgent need for therapeutic strategies to prevent the spread of COVID-19 in this vulnerable population. We are proud to be a part of this new type of clinical study for preventive treatment,” Ramirez said.
For this trial, Lilly deploys mobile research units to a long-term care site soon after an individual has tested positive for SARS-CoV-2. The unit team enrolls residents and staff members who volunteer to participate in the trial. The one-time study drug infusion and follow-up visits are administered to study volunteers at the long-term care facility. The UofL team works with the Lilly team during the initial site infusions and will monitor participants following the infusion for up to 25 weeks.
The first deployment in Kentucky was to Essex Nursing and Rehabilitation Center, where 20 residents and staff members were enrolled in the study in November.
“Our elderly population is at a much higher risk of complications from COVID-19 and our staff and residents are happy to be participating in this study. I have personally witnessed the negative impact COVID-19 has had on nursing facilities,” said Robert Flatt, Essex administrator. “I am extremely proud to be an active participant in this collaborative study in the hopes that we will soon put an end to this pandemic.”
The virus is known to spread rapidly among staff and residents of long-term care facilities, who account for a high percentage of hospitalizations and deaths resulting from the virus.
“I am glad to be a part of this research study with the University of Louisville to help find treatment and prevention options for COVID-19. As a member of our community, I am happy to participate in the hopes of helping others. I am also excited to participate as I am a huge fan of the University of Louisville,” said Patricia L. Rollie, an Essex resident and study participant.
Antibodies are produced naturally by the immune system in response to viruses and other foreign invaders and help the body neutralize and destroy these threats. However, it takes time for the body to produce its own antibodies. Bamlanivimab is an antibody engineered from a COVID-19 survivor. Testing and previous trials have shown that manufactured antibodies can speed recovery or possibly prevent SARS-CoV-2 infection.
“COVID-19 has had a devastating impact on nursing home residents. We’re working as fast as we can to create medicines that might stop the spread of COVID-19 to these vulnerable individuals,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories. ”BLAZE-2 is a first-of-its-kind COVID-19 trial designed to address the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials.”
As a result of a separate clinical trial, Lilly has received an emergency use authorization from the FDA for bamlanivimab to treat higher-risk patients recently diagnosed with mild-to-moderate COVID-19.
Bamlanivimab targets the spike protein of the SARS-CoV-2 virus. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus and potentially preventing and treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera and was discovered by AbCellera and scientists at the National Institute of Allergy and Infectious Diseases Vaccine Research Center.