Eli Lilly has started a phase 3 trial to evaluate whether its antibody LY-CoV555 stops the residents of nursing homes from developing COVID-19.
Lilly has created customized mobile research units to run the clinical trial at nursing homes as the long-term care facilities lack experience running studies.
More than 40% of all U.S. deaths from COVID-19 involve nursing home residents and staff, according to a New York Times analysis, despite just 8% of cases occurring in such facilities. In 20 states, nursing homes account for more than half of all COVID-19 deaths. Eighty-two percent of COVID-19 deaths in New Hampshire involve nursing homes.
The disproportionate burden borne by nursing homes suggests immunizing residents and workers at long-term care facilities against the pandemic SARS-CoV-2 virus could significantly reduce the death toll. However, the limited response of seniors to vaccines may make it hard to provide protection.
Antibodies provide an alternative, and in seniors potentially more effective way, to protect people against the coronavirus. Infusing anti-SARS-CoV-2 into people at risk of exposure to the virus could provide temporary protection against the pandemic pathogen.
Lilly is putting that idea to the test. Having started the first clinical trial of a potential COVID-19 antibody two months ago, Lilly has now initiated a phase 3 trial to assess the prophylactic potential of LY-CoV555.
The trial will enroll up to 2,400 residents and staff at nursing homes that have recently had a case of COVID-19. By targeting facilities with confirmed cases of COVID-19, Lilly stands to accelerate the task of showing whether LY-CoV555 protects against the virus. Lilly will assess the effect of a single dose of LY-CoV555 on the rate of infection and complications of COVID-19 for four weeks and eight weeks, respectively.
Lilly, working with the National Institute of Allergy and Infectious Diseases, the COVID-19 Prevention Network and nursing home networks, has sought to counter the challenges of running clinical trials in long-term care facilities. Specifically, Lilly has customized recreational vehicles to support mobile labs and the preparation of clinical trial materials. A trailer truck will deliver the clinical trial supplies required to set up on-site infusion clinics. Lilly will use the fleet to address outbreaks across the U.S.
The mobile research units are needed as long-term care facilities rarely run clinical trials and, as such, lack the infrastructure and expertise to execute the study. Under normal circumstances, participants may travel to clinical trial sites for treatment and monitoring, but that is potentially unsafe today.
Other companies are assessing anti-SARS-CoV-2 antibodies in more conventional clinical trials. Last month, Regeneron began a phase 3 trial to test the prophylactic power of its REGN-COV2 antibody cocktail in uninfected people who have recently been exposed to COVID-19 patients. The protocol of that trial, which is enrolling at 100 U.S. study centers, specifically excludes nursing home residents.
In finding a way to evaluate LY-CoV555 at nursing homes, Lilly has positioned itself to carve out a niche in the busy anti-SARS-CoV-2 antibody space by serving a population that particularly needs the protection it may be able to provide.
By: Nick Paul Taylor
Source: Fierce Biotech
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