A U.S. pharmaceutical company is attempting to build out a full clinical trial for a drug that could potentially prevent COVID-19 infections — among other viral ailments — in long-term care settings.
The Tampa, Fla.-based Romark Laboratories has high hopes for its NT-300 drug, an existing oral medication that works by preventing a virus from replicating inside of a host, according to CEO Marc Ayers.
The active ingredient, nitazoxanide, has also been used in the treatment of certain intestinal infections caused by protozoa, Ayers said.
“We believe that there’s an opportunity to take a product like this, that has a broad spectrum of activity, and to be able to use it for treating not just seasonal strains of viruses that have a significant impact on the elderly population in particular, but also certainly on emerging strains like COVID-19 — as well as, for example, drug-resistant strains, strains that may be resistant to Tamiflu,” he said, referring to the brand name of a common antiviral drug used to treat and prevent influenza.
But given the vulnerable nature of nursing home residents, and uncertainty regarding the ongoing spread of the novel coronavirus, the phase-three clinical trial faces additional challenges.
Romark has already enrolled about 15 to 20 long-term care sites, including private facilities and buildings operated by the VA, in the program, but it ultimately needs about 800 total residents to achieve sufficiently thorough results, Ayers said; a separate trial will focus on 800 workers at risk of contracting COVID-19.
And even if leadership at a given facility wants to host the Romark trial, they can only participate if there are active COVID-19 cases — a situation that fortunately isn’t the case in the majority of properties nationwide, at least according to the most recent data from the federal government. Several buildings that have signed onto the trial remained COVID-free as of SNN’s conversation with Ayers late last week.
In addition, residents with dementia are barred from the trial, given their inability to provide informed consent, and clinicians involved in the study must follow Centers for Disease Control & Prevention (CDC) guidelines around infection control when conducting their work.
“We explain the requirements of the protocol to them, and work with them as well as possible,” Ayers said of the informed-consent process for residents. “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.”
Nursing homes have served as the epicenter of the COVID-19 crisis in the United States; the congregate living setting, frail nature of the residents, and chronic issues around underfunding and infection control have all conspired to make institutional long-term care settings the perfect environment for the virus to thrive and do the most damage.
As of May 31, nearly 32,000 people have died of COVID-19 infections nursing homes per the Centers for Medicare & Medicaid Services’ (CMS) official tally, with more than 95,000 positive cases — though that data is incomplete and the numbers are expected to rise with future updates.
While seasonal influenza outbreaks often cause sickness in death in nursing homes, administrators have the benefit of a vaccine and other proven treatments such as Tamiflu. Until such options emerge for COVID-19, operators can only focus on prevention and palliative measures for those who become infected.
Interested parties can call Romark’s headquarters in Tampa to learn more about the study, Ayers said.
“We’re anxious to work, and we’re working with a sense of urgency to try to address this situation,” he said. “We’re anxious to work with anybody that is willing to work with us.”
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