INDIANAPOLIS — Eli Lilly and Company announced Monday that a Phase 3 trial will study its drug designed to prevent COVID-19 at long-term care facilities in the U.S.
The drug, LY-CoV555, will be studied in nursing homes and assisted living facilities.
Lilly's announcement of the study describes LY-CoV555 as "a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19." It is designed to block viral attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19.
"COVID-19 has had a devastating impact on nursing home residents," reads Lilly's statement on the need for the antibody. "We're working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals. 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," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.
Lilly is partnering with the National Institute of Allergy and Infectious Diseases on the trial, which is already underway.
The next phase of the study named "BLAZE-2" is a first-of-its-kind COVID-19 trial that will enroll residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who are now at a high risk of exposure.
It will be testing whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through 4 weeks, as well as complications of COVID-19 through 8 weeks. Up to 2,400 people will participate in the study.
Lilly has created mobile research units to support the on-site studies. These mobile units consist of a custom RV to support mobile labs and clinical trial material preparation, along with a trailer truck to deliver to supplies needed to create an on-site clinic. Additional staff will help with the operations of the study.
Lilly plans to deploy its mobile research unit fleet where outbreaks of the virus occur at long-term care facilities across the U.S.
More information about the study and how to enroll is is included in Lilly's announcement.
CORRECTION: An earlier version of this report indicated the next phase of trials would begin next month. They are underway now, according a Lilly spokesperson.