August 3, 2020 -- Eli Lilly has begun a phase III trial of its lead COVID-19 antibody treatment candidate, Ly-CoV555.
The Blaze-2 trial will investigate whether Ly-CoV555 can prevent COVID-19 among residents and staff at long-term care facilities, which have been uniquely impacted by viral outbreaks.
The candidate is a potent, neutralizing immunoglobulin G1 (IgG1) monoclonal antibody (mAb) directed against the novel coronavirus's spike protein, the company noted. Lilly is also investigating Ly-CoV555 in a randomized, double-blind phase I trial that is currently being conducted by medical centers in the U.S.
The Blaze-2 trial will evaluate the safety and efficacy of Ly-CoV555 for preventing infection and test whether a single dose can reduce infection rates and COVID-19 complications. It will enroll up to 2,400 participants who are at a high risk of novel coronavirus exposure due to living or working in a facility with a recently diagnosed COVID-19 case.
The trial is being conducted as a partnership among Lilly, the U.S. National Institute of Allergy and Infectious Diseases, the COVID-19 Prevention Network, and several long-term care facilities in the U.S. To meet the challenges of conducting a clinical trial in a long-term care facility, Lilly has created custom mobile research units that included retrofitting recreational vehicles with mobile labs and trailer trucks to deliver clinical trial supplies.