The Phase 3 trial will initially enroll some 300 volunteers around the world who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms. Over the following weeks, Regeneron Pharmaceuticals moved a rival candidate into the clinic and AstraZeneca outlined plans to start testing its COVID-19 antibody asset in humans by August.
The Indianapolis-based drugmaker said it dosed the first participant in the placebo-controlled trial at a nursing home in IL.
"We commend Lilly and NIH in recognizing the critical need for developing medicines to combat the spread of the virus among some of the most vulnerable populations", said Dr. Alexander Stemer, an infectious disease expert and co-chair of Symphony Care Network's COVID-19 task force.
To expedite the study, Lilly has created mobile research units to support the on-site aspects of the investigation.
Lilly's drug, developed in collaboration with Canadian biotechnology company AbCellera Biologics Inc., was derived from the blood sample of one of the first Americans to recover from Covid-19 earlier this year. This includes custom retrofitted recreational vehicles (RV) that will support mobile labs and clinical trial material preparation.
They will be given one dose of the antibody - isolated from one of the first Covid-19 patients to recover in the US - to see how it can reduce infection rates, or treat those already infected, in four and eight weeks' time respectively, the company said in a press release.
Daniel said that clinical trials are not easy in the current environment. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the U.S.
"These facilities aren't typically set up for conducting clinical trials right", said Adams.
"The mission of the COVID-19 Prevention Network is to conduct Phase 3 vaccine and monoclonal antibody efficacy studies for the prevention of COVID-19", said Myron Cohen, M.D., director of UNC's Institute for Global Health and Infectious Diseases and a CoVPN leader.
Participants will be given one dose of LY-CoV555, and will be monitored while researchers determine its ability to reduce infection rates and treat those who have already been infected with the virus.