The trial will assess a monoclonal antibody based investigational treatment that may prevent COVID-19.
Eli Lilly and Company has announced the start of a phase 3 trial for prevention of SARS-CoV-2 infection in residents and staff at long-term care facilities in the United States, using a monoclonal antibody candidate known as LY-CoV555.
The study, named BLAZE-2, will enroll as many as 2400 residents and staff in nursing homes. The study team will use a fleet custom mobile research units to conduct the trial on-site at various facilities.
In a press release, Lilly's chief scientific officer highlighted the motivations for the study.
"COVID-19 has had a devastating impact on nursing home residents. 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," Daniel Skovronsky, MD, PhD, said. "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."
The study will center on facilities that have had a recently diagnosed case of COVID-19 and are at risk of an outbreak. The study endpoints will be to evaluate the efficacy and safety of LY-CoV555 for the prevention of SARS-CoV-2 infection, assessing whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through 4 weeks, and seeing if the candidate reduces complications of COVID-19 through 8 weeks.
The mobile research units will use a retrofitted RV along with a trailer truck that will carry the medical supplies necessary to create an on-site infusion clinic. Additional staff will be at the facilities to help conduct a study in this unusual environment.
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. The antibody treatment candidate was identified from a blood sample taken from one of the first US patients to recover from COVID-19.
More than 40% of deaths caused by COVID-19 in the US are linked to long term care facilities.
Despite clear record of violations across the country, amid a culture where sick staff were asked to show up for work, lawmakers in several states have also potentially disincentivized improvement of infection control standards by providing legal liability protections to these facilities ahead of time.
Direction of testing, PPE, and future authorized therapeutics (such as monoclonal antibody therapies) will be vital to reversing this course.