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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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COVID-19, Viral Respiratory Illnesses

Intervention / Treatment
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* Drug: Nitazoxanide
* Drug: Placebo
* Dietary Supplement: Vitamin Super B-Complex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitazoxanide<br>Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks | Drug: Nitazoxanide<br>* Nitazoxanide 600 mg administered orally twice daily for six weeks<br>* Other names: NT-300;Dietary Supplement: Vitamin Super B-Complex<br>* Vitamin Super B-Complex administered orally twice daily to maintain the blind<br>|
| Placebo Comparator: Placebo<br>Two placebo tablets orally twice daily for 6 weeks | Drug: Placebo<br>* Placebo administered orally twice daily for six weeks<br>Dietary Supplement: Vitamin Super B-Complex<br>* Vitamin Super B-Complex administered orally twice daily to maintain the blind<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic laboratory-confirmed COVID-19 | The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. | up to 6 weeks | 
| Symptomatic laboratory-confirmed VRI | The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. | up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Viral Respiratory Illnesses