COVID-19 clinical drug trial underway in Cullman, seeking patients

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Cullman Clinical Trials staff, left to right: Justin Wilson CRNP, Greg Bostick M.D., Cheryl Hargrove MA and Managing Partner Alex Seligson (Photo courtesy of CCT)

CULLMAN, Ala. – Cullman Clinical Trials (CCT), a medical research group affiliated with Cullman Primary Care, began a trial this week of a drug that may be able to combat the symptoms of COVID-19 and keep patients healthier through the progress of the disease. Participants will receive medical services and financial compensation. 

CCT Managing Partner Alex Seligson told The Tribune, “We just started one this week for a treatment for COVID-19 patients and it’s for a drug called Nitazoxanide. This drug has been on the market for over a dozen years, and the purpose of it right now is to treat patients that have a parasitic infection.”

Nitazoxanide is often used to control diarrhea in cases of parasitic infection, helping to control a potentially dangerous symptom of the infection. An April 2020 report from the National Institutes of Health noted that the drug had been “previously suggested but widely ignored” in COVID research, but pointed to potential benefits from its use in combination with azithromycin or hydroxychloroquine, especially when administered as early as possible after the onset of symptoms.

According to Seligson, the drug can help control fever as well as diarrhea.

“They’re trying to prove that it’s purposeful in helping COVID patients, helping (keep) the disease from progressing,” he said, “keeping their temperatures down, helping with respiratory symptoms, trying to keep them out of the hospital and away from death situations.”

Seligson shared CCT’s description of the trial:

Clinical trial for the use of Nitazoxanide for the treatment of COVID 19 and symptoms. 

The purpose of this anti-viral drug is to subdue the symptoms including fever and respiratory issues. This is a double blind placebo controlled trial meaning half of the patients will get the active medication and the other half will receive a placebo. Participants do not need to be diagnosed with COVID 19 but do have to have some symptoms. Cullman Clinical Trials is affiliated with Cullman Primary Care but anyone who has symptoms may participate in the trial. Eligible participants will receive study medication, doctor visits, COVID and antibody tests and compensation of $690.

The Cullman trial is part of a national study expected to include around 2,000 patients. Such a trial in a city the size of Cullman, especially without a teaching hospital or medical school, is unusual.

Said Seligson, “It’s interesting that they’re doing it in Cullman, because a lot of these trials are only being done in the big academic medical centers like the UABs and the Vanderbilts. We’re an independent research facility and we work in Cullman and we do things like fatty liver disease and rheumatoid arthritis and pediatric vaccinations- very common medications for that. You know, we’re really excited to kind of bring a COVID treatment, because it’s an opportunity for anybody who has symptoms- you don’t even have to have a COVID diagnosis- because one of the things they found with this medication: you’ve got to hit it early. If you can hit it within the first three days of symptoms with this anti-viral, they’re trying to prove that it’ll subdue the symptoms and keep the patients, the severity of the virus, from getting worse.”

The trial began Wednesday with two patients, but CCT is still taking applications. Seligson hopes to see at least 100 participants in the Cullman study.

To those who might be concerned about health and safety in such a trial, Seligson said, “With any clinical trial, there’s always a risk; however, that risk is mitigated by the fact that this medication has been on the market for over a dozen years, and side effects have been quite minimal. If anything, diarrhea and headaches have been the most common negative side effects from this, so I think the positives greatly outweigh the negatives with this potential treatment.”

If you are interested in taking part in the trial, visit www.cullmanclinicaltrials.com or call 256-708-2826.

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W.C. Mann

craig@cullmantribune.com