Official Title
A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)
Brief Summary

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Detailed Description

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and

safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF

residents.

Recruiting
COVID-19
Viral Respiratory Illnesses

Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Nitazoxanide
Other Name: NTZ (nitazoxanide)
Other Name: NT-300

Drug: Placebo
Placebo administered orally twice daily for six weeks
Placebo

Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Nitazoxanide
Placebo

Eligibility Criteria

Inclusion Criteria: - Male and female residents of LTCFs at least 55 years of age. - Willing and able to provide written informed consent and comply with the requirements of the protocol. - At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Exclusion Criteria: - Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary. - Subjects expected to require hospitalization within the 8-week treatment and follow-up period. - Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies. - Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1. - Receipt of any dose of NTZ within 7 days prior to screening. - Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study. - Known sensitivity to NTZ or any of the excipients comprising the study medication. - Subjects unable to swallow oral tablets or capsules. - Subjects taking medications considered to be major CYP2C8 substrates. - Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Eligibility Gender
All
Eligibility Age
Minimum: 55 Years~Maximum: 120 Years
Countries
United States
Locations

The Chappel Group Research
Kissimmee, Florida, 34744

Recruiting

Investigator: Romark
Contact: 877-925-4642

Clinical Trial Specialists, Inc.
Acworth, Georgia, 30101

Recruiting

Investigator: Romark
Contact: 877-925-4642

Centex Studies, Inc.
Lake Charles, Louisiana, 70601

Recruiting

Investigator: Romark
Contact: 877-925-4642

Centex Studies, Inc.
Houston, Texas, 77058

Recruiting

Investigator: Romark
Contact: 877-925-4642

Contacts

Matthew Bardin, PharmD, BCPS
813-282-8544
matthew.bardin@romark.com

Romark Laboratories L.C.
NCT Number
Keywords
Covid-19
Viral Respiratory Illnesses
MeSH Terms
Nitazoxanide