Eli Lilly, in alliance with the US National Institute of Allergy and Infectious Diseases (NIAID), has launched the Phase III BLAZE-2 clinical trial LY-CoV555 to prevent Covid-19 in residents and staff at long-term care facilities.
Developed in partnership with AbCellera, LY-CoV555 is a IgG1 monoclonal antibody against SARS-CoV-2, the coronavirus that causes Covid-19.
The study will involve residents and staff who live or work at long-term care facilities that have recently been diagnosed Covid-19 and are now at high risk of exposure. It is set to recruit up to 2,400 volunteers in the US.
It will assess the safety and efficacy of LY-CoV555 in preventing SARS-CoV-2 infection and Covid-19.
A single dose of the drug candidate will be tested for its ability to decrease the rate of infection up to four weeks and Covid-19 complications up to eight weeks.
Eli Lilly chief scientific officer Daniel Skovronsky said: “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.
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“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.”
The company developed customised mobile research units to support the on-site study at long-term care facilities during the pandemic.
These mobile research units comprise a retrofitted recreational vehicle (RV) for mobile labs and clinical trial material preparation, as well as a trailer truck to deliver clinical trial supplies for an on-site infusion clinic.
Additional staff will be available at the facilities to help with the study activities.
In June this year, Lilly started patient enrolment for a Phase III trial of baricitinib to treat adults hospitalised due to Covid-19.