Eli Lilly and Co. on Monday announced that it will test a COVID-19 antibody treatment with the help of assisted living and nursing home residents and staff members. The study will enroll up to 2,400 people.
“While it’s not easy to conduct clinical trials in this setting, we’re taking on the challenge in an effort to help those who need us the most,” Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a statement.
The pharmaceutical company announced the beginning of BLAZE-2, the third phase of a trial of the antibody treatment, LY-CoV555, against SARS-CoV-2, the virus that causes COVID-19. The study is being conducted in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health; the COVID-19 Prevention Network; and several long-term care facility networks across the country. The Food and Drug Administration reviews results from Phase 3 trials as part of its approval process.
The study will enroll assisted living and nursing home residents and staff members who have had recently diagnosed cases of COVID-19 and who now are at high risk of exposure. It will evaluate the safety and effectiveness of LY-CoV555 in preventing infection and COVID-19 and also test whether a single dose reduces the infection rate and COVID-19 complications.
Clinical trials typically take place in hospitals, universities, physicians’ offices and community clinics. so Lilly said it has created customized mobile research units to address the challenging aspects of running a clinical trial in a long-term care facility during a pandemic. These units include a custom retrofitted recreational vehicle to support mobile labs and clinical trial material preparation, along with a trailer truck that will deliver all clinical trial supplies needed to create an on-site infusion clinic.
To further minimize the burden on the long-term care facilities, additional staff members will be on site to assist with the study. Lilly said it will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the United States.
“We are grateful to the NIAID team for their exceptional partnership on this innovative trial, and we are deeply appreciative of the care facilities, their staff and the many residents who will be participating in this important study,” Skovronsky said.
One of the long-term care organizations participating in the trial is the Symphony Care Network, which includes assisted living and transitional care.
“We commend Lilly and NIH in recognizing the critical need for developing medicines to combat the spread of the virus among some of the most vulnerable populations,” Alexander Stemer, M.D., a board-certified infectious disease expert and co-chair of Symphony Care Network’s COVID-19 task force, said in a statement. “As the scientific community searches for safe and effective therapies for COVID-19, we are proud to participate in this leading-edge study given its potential to save lives.”