Pharmaceutical giant Eli Lilly and Company (NYSE: LLY) will soon begin a phase-three clinical trial of a potential coronavirus treatment in the long-term care setting, with nursing home operator Symphony Care Network as a partner.
Up to 2,400 residents and staff of nursing homes and assisted living properties will participate in the on-site study, the Indianapolis-based Eli Lilly announced Monday, with a focus on facilities with recent positive cases.
“We’re working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals,” Dr. Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories, said in a statement. “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 drugmaker has already conducted two trials of the drug, LY-CoV555, in hospitals and ambulatory care settings. While data regarding its effectiveness remains pending, Lilly reported that researchers have found no severe adverse effects during the first two rounds of trials.
LY-CoV555 is a neutralizing antibody for a key protein produced by the novel coronavirus, leading researchers to hypothesize that it could help both prevent and treat COVID-19 infections.
Lilly developed the antibody for potential pharmaceutical use in conjunction with the Vancouver-based biotech firm AbCellera; the long-term care study will be conducted in collaboration with the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), as well as the COVID-19 Prevention Network (CoVPN).
In particular, the study will determine if one dose of LY-CoV555 can reduce the likelihood of infection over the course of four weeks, and prevent complications related to COVID-19 over eight weeks.
Conducting a drug trial in the nursing home setting, with subjects that are more vulnerable both mentally and physically than the general public, presents even more challenges than a typical study, even without the COVID-19 visitation restrictions currently in place in many states.
The Tampa, Fla.-based Romark Laboratories, for instance, automatically excluded all residents with dementia from its nursing home-based study of a potential COVID-19 prophylactic drug called NT-300.
“We explain the requirements of the protocol to them, and work with them as well as possible,” Romark CEO Marc Ayers told SNN in June, referring to its informed-consent strategy. “We work with the staff at the long-term care facilities. We minimize visitation to the extent possible — only where the study physician is required to see the patients for illnesses. We work by telephone as much as possible, and just try to create an environment that is conducive to completing the clinical trial while being as least intrusive as possible on the facility.”
For the CoV555 study, Lilly will supply recreational vehicles and trailer trucks to create temporary infusion clinics and mobile labs at participating nursing facilities, the company announced, while also providing additional workers to help the ease the burden on building staff.
Multiple long-term care companies will participate in the trial, according to Lilly; only one, the Chicagoland-based Symphony Care Network, was explicitly named in the drugmaker’s Monday announcement.
“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,” Dr. Alexander Stemer, co-chair of Symphony Care Network’s COVID-19 task force, said in a statement. “As the scientific community searches for safe and effective therapies for COVID-19, we are proud to participate in this leading-edge study given its potential to save lives.”