Clinical Trials Test New Drug for Prevention of COVID-19 in Elderly Residents

Marc Ayers, CEO, Romark Pharmaceuticals

While efforts like social distancing and wearing PPE have helped slow the spread of COVID-19, the development of a vaccine or treatment would provide us with valuable tools to better fight the virus. Many efforts to develop a vaccine or treatment are underway, but one set of clinical trials is focusing on the long-term care center setting.

The Romark Pharmaceuticals Phase 3 Clinical Trials of NT-300

Romark Pharmaceuticals’ clinical trials test the effectiveness of its broad-spectrum antiviral NT-300, nitazoxanide extended-release tablets, in preventing viral respiratory infections like COVID-19. These trials focus on the drug’s effectiveness in protecting high-risk populations, including residents and staff in senior care facilities.

“We’re working to develop a broad-spectrum antiviral drug for treating and preventing viral respiratory illnesses, in particular COVID-19,” explains Marc Ayers, CEO of Romark Pharmaceuticals. “We’ve been working on this for quite a number of years and currently, we’re in the very final stages of completing the clinical trials that are required for licensure.”

NT-300’s performance has been encouraging. In lab studies, the drug has been shown to inhibit the replication of many respiratory viruses, including SARS, MERS, influenza viruses, rhinoviruses, and the SARS-CoV-2 virus that causes COVID-19. These new trials focus on how the drug may be used to fight COVID-19.

Romark Pharmaceuticals is running three trials:

• The first prevention trial will enroll 800 senior residents in long-term care facilities after COVID-19 is reported at each facility.
• The second prevention trial will enroll 800 healthcare workers who are at risk of being exposed to COVID-19.
• The third trial will focus on NT-300’s effectiveness as an early treatment of COVID-19 and other viral respiratory illnesses.

“We started those prevention trials in May and they are enrolling patients,” says Ayers. “We are expecting to complete them by the end of the summer.” Ayers also notes that the third trial focusing on NT-300 as a treatment should begin by the end of July. That trial is also expected to be completed by the end of the summer.

NT-300 offers several potential advantages if it proves effective in these trials. “It’s an oral drug,” notes Ayers, “while a lot of the drugs that are being proposed are IV-administered in hospitals. We can administer NT-300 to patients outside of hospitals. Rather than focusing on getting patients out of a hospital, we can focus on keeping them out of hospitals in the first place.” NT-300 also has “a very reasonable safety profile,” Ayers explains. “We haven’t seen any resistance to the drug.”

Participate in the Clinical Trials

You can learn more about the trials on the ClinicalTrials.gov website. All three trials are actively enrolling and should be completed by the end of the summer, so interested participants and their doctors should promptly inquire about enrollment.

The Next Steps

Results of the clinical trials will be published in a medical journal, and you can visit Romark Pharmaceuticals’ website for updates as the trials are concluded. If the trials are successful, Romark Pharmaceuticals is prepared to quickly move forward with production.

“We’re already gearing up manufacturing to be able to deliver this drug during the fourth quarter of 2020. Our path would be to get these trials completed, seek an emergency use authorization as soon as the data is available, and then follow that with an application for full formal marketing approval,” says Ayers.

In summary, Ayers explains that Romark Pharmaceuticals is working to develop a solution that can help to prevent or treat an illness like COVID-19 early on, before it becomes severe. “I think we have a really important opportunity to make an impact on the pandemic and its course if we’re able to do that,” he notes.

“In particular, we’re concerned about people at very high risk, like long-term care facility residents and workers. The everlasting impact that this crisis has had on them is no secret. We’re looking for any opportunity to collaborate with others and also to be able to help.”

Paige Cerulli

Paige Cerulli is a contributing writer to i Advance Senior Care.