A phase 3 trial evaluating LY-CoV555 for the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in residents and staff of long-term care facilities has been initiated by Lilly.
LY-CoV555 is a potent, neutralizing lgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. The investigational therapy is expected to block viral attachment and entry into human cells.
The BLAZE-2 trial is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the COVID-19 Prevention Network. The study is expected to enroll up to 2400 participants; eligible individuals are those who live and work in long-term care facilities and are at elevated risk due to recent cases of COVID-19. Study participants will be administered a single dose of LY-CoV555 and will be followed for 8 weeks.
According to Lilly, BLAZE-2 is a “first-of-its-kind” COVID-19 trial. Given the challenges with running a clinical trial in a long-term care facility, the Company has created customized mobile research units to support mobile labs and clinical trial material preparation. “COVID-19 has had a devastating impact on nursing home residents. 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, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories.
LY-CoV555 is also being assessed in a phase 2 study (BLAZE-1) in individuals recently diagnosed with COVID-19 in the ambulatory setting. Full data from this trial are expected in the fourth quarter of 2020.
For more information visit lilly.com.
Lilly initiates phase 3 trial of LY-CoV555 for prevention of COVID-19 at long-term care facilities in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). https://www.prnewswire.com/news-releases/lilly-initiates-phase-3-trial-of-ly-cov555-for-prevention-of-covid-19-at-long-term-care-facilities-in-partnership-with-the-national-institute-of-allergy-and-infectious-diseases-niaid-301104445.html. Accessed August 3, 2020.