On Aug. 3, 2020, Eli Lilly announced the initiation of BLAZE-2, a phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly created an urgent need for therapies to prevent COVID-19 in this vulnerable population.

The Lilly-sponsored BLAZE-2 study is a first-of-its-kind COVID-19 trial and is being conducted in partnership with NIAID, part of the National Institutes of Health (NIH), along with the COVID-19 Prevention Network (CoVPN) and several long-term care facility networks across the country. The study 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 evaluate the efficacy and safety of LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19, 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. It is expected to enroll up to 2,400 participants.

To address the challenging aspects of running a clinical trial in a long-term care facility during a pandemic, Lilly created customized mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle (RV) 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 these facilities that normally do not conduct clinical trials, additional staff will be at the facilities to assist with the operations of the study. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the U.S.