Another antiparasitic drug has emerged as a potential treatment for COVID-19, and trial site organization in Cullman, Alabama, called Cullman Clinical Trials, will be conducting a study to determine if this repurposed drug can be used to fight the coronavirus. This research site seeks 800 participants to test nitazoxanide and its potential to treat COVID-19. Cullman Clinical Trials is affiliated with Cullman Primary Care, and this relationship assures access to more patients than the typical independent trial site organization. Can a repurposed antiparasitic, rebranded as NT-300, reduce the impact of COVID-19? A Northern Alabama research site partners with sponsor Romark Laboratories to find out.
What is Nitazoxanide?
Produced by Romark Laboratories, this antiparasitic drug has been found to inhibit a broad range of respiratory pathogens in cell cultures, and this includes SARS-CoV-2, the virus behind COVID-19. Nitazoxanide was approved by the U.S. Food and Drug Administration (FDA) by 2002 as a treatment for diarrhea caused by the water-borne parasitic infection Cryptosporidium under the trade name Alinia.®
By April, Romark Laboratories announced the intention to test its new drug candidate, NT-300, based on the FDA approved drug nitazoxanide, against COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
The company uncovered that in cell cultures, the active ingredient in NT-300 (nitazoxanide) inhibits the replication of a broad range of respiratory viruses, including SARS-CoV-2. Interestingly, this is similar to another FDA approved antiparasitic drug, ivermectin.
Nitazoxanide has been shown to inhibit the replication of SARS, MERS, and other coronaviruses as well as influenza viruses, rhinoviruses, parainfluenza viruses, RSV, and others in cell culture studies. This substance’s broad-spectrum antiviral activity is based on its ability to interfere with human cellular pathways that viruses are known to exploit for replication, rather than to a virus-targeted mechanism.
For any safety issues, see the FDA label.
Clinical Trials Involving NT-300
Presently, Romark is sponsoring three clinical trials involving NT-300, including NCT04486313, NCT04359680, and NCT04343248. There are several other trials around the world involving generic Nitazoxanide targeting COVID-19.
Cullman Alabama Study
Cullman Clinical Trials is participating in NCT04486313. The recent report from the local press Cullman Times mentioned that the study drug is administered for five (5) days. This is the only one of the studies that includes that same regimen protocol.
Officially titled “Phase 3, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19,” the Phase 3, multicenter study involves a target of 800 patients. The study started in August 2020 and runs till October 30, 2020. Patients will be given two nitazoxanide 300 mg tablets twice daily for five days, and Vitamin Super B-Complex administered orally twice daily to maintain the blind.
The study’s primary outcome measure includes time (up to 21 days) to evaluate the study drug’s effect in reducing the time to sustained response compared to placebo in subjects with mild to moderate COVID-19. The secondary outcome measure involves the time (up to 21 days) to reduce the progression rate to severe COVID-19 illness compared to placebo.
As reported in another press release, Cullman Clinical Studies is affiliated with Cullman Primary Care, and those people who go to Cullman Primary Care with COVID-19 symptoms and meet the clinical trial’s criteria will be asked if they want to take part in the study to test the efficacy of the drug.
According to Clinicaltrials.gov, the sponsor is using clinical research services provider Celerion.
Cullman Clinical Trials Background
This Cullman, Alabama-based trial site organization called Cullman Clinical Trials, is a private based provider of clinical trials services. They aim to improve treatments and provide advancements in primary care and multi-specialties that result in better future health for all patients, providers, and sponsors.
Currently, the trial site organization runs studies involving NASH, rheumatoid arthritis, and psoriatic arthritis, as well as the COVID-19 study sponsored by Romark Laboratories.
Cullman Clinical Trials is affiliated with Cullman Primary Care, which has provided family-centered care to Northern Alabama since 1990.
With its U.S. headquarters of Romark based in Tampa, Florida, Romark is a vertically-integrated, research-based pharmaceutical company focused on discovering, developing, and delivering innovative new medicines, primarily in the field of infectious diseases. Romark has operations in the United States, Puerto Rico, and Europe, and it conducts research and development and commercializes its products globally.
The company positions that it’s a leader in developing new drugs for treating a broad range of seasonal, emerging, and drug-resistant viral respiratory illnesses. With over 1,000 patents, the company’s drugs are used to positively impact the lives of over 400 million people worldwide.
According to the company’s Linkedin posting, they were founded in 1994 and employ about 200.
Call to Action: According to Clinicaltrials.gov, the study contact is Stefan Comhaire, Executive Director Global Clinical Development at Celerion, the CRO for the study. For those interested in participating (or have family members), contact Cullman Clinical Trials.