The experimental use of monoclonal antibodies in nursing homes during the COVID-19 crisis may finally persuade drugmakers to enroll residents in future drug trials, according to one long-term care executive.
Last year, Principle LTC partnered with Eli Lilly to offer access to a Phase 3 clinical trial of the drug Bamlanivimab, or BAM, during COVID-19 outbreaks. That trial and a related study have been heralded for providing successful treatment and a preventative effect that dramatically reduced the risk of contracting symptomatic COVID-19 among nursing home residents.
Principle President and CEO Lynn Hood gives the monoclonal antibodies partial credit for her chain’s success in battling COVID, including a 95-97% survival rate at four special care units Principle began operating during the pandemic.
Hood also predicts the trial’s success inside skilled nursing facilities will encourage drugmakers to partner more often with providers whose residents have complex medical needs. That complexity — and concerns about consent — have long made nursing homes untouchable when it comes to clinical trials, even in the case of drugs designed for their residents.
Principle, which operates 46 sites in North Carolina, Virginia and Kentucky, is already in talks with Lilly about future pharmaceutical trials.
“It’s the first time in my years — and I started in the ’70s — that a research trial around pharmaceuticals came to us,” Hood, a former HCR ManorCare executive, told McKnight’s Long-Term Care News. “There’s never been a drug trial done in a nursing home, period, full stop… Now we’re talking about what more we can do because there are big diseases out there, like Alzheimer’s disease and cancers, that may be able to have similar results with monoclonal antibodies and RNA treatments. We want to be part of that.”
Drugmakers’ reluctance to evaluate new drugs inside skilled nursing homes isn’t a new issue, and nursing homes have traditionally shied away too.
“Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments’ generalizability, efficacy and safety,” a team reported in the American Journal of Public Health more than a decade ago.
Senior advocates raised lack of representation as a major issue again in 2020, as the nation rushed to create COVID-19 vaccines.
“When we get to nursing homes … we [may be] making decisions about folks who’ve never been tested,” geriatrician Michael Wasserman, M.D., warned last fall.
Eager to innovate
Hood said her corporate medical director was eager to partner with Lilly. Though Lilly staff delivered the drugs and administered them at six of the chain’s 36 North Carolina sites, Principle also implemented a series of logistical measures to ensure safety and success.
A prophylactic trial began in summer, followed by the December start of a trial intended to weigh the drug’s treatment capabilities when given alone or in combination with Etesevimab.
For both, Principle used SharePoint to securely exchange information with Lilly when patients were identified as potential candidates. Lilly could then work to attain patient or family permission for enrollment and determine if the patient met the strict medical requirements of the trial. Hood also spoke with a Lilly executive two nights a week to iron out concerns.
She sees the partnership as proof that skilled nursing providers can be both innovative and aggressive when it comes to caring for their residents.
Chad Worz, executive director and CEO of the American Society of Consultant Pharmacists, underscored the need to focus pharmaceutical research on long-term care residents moving forward.
“COVID-19 created a necessity for that in both the vaccine and the monoclonal antibody treatments,” he said Monday. “Hopefully, this experience paves the way for more research on treatments that improve quality of life for people living in skilled nursing homes.”