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)
NCT ID: NCT04343248
Last Updated: 2024-07-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
190 participants
INTERVENTIONAL
2020-05-12
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Placebo
Two placebo tablets orally twice daily for 6 weeks
Placebo
Placebo administered orally twice daily for six weeks
Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Interventions
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Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Placebo
Placebo administered orally twice daily for six weeks
Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
120 Years
ALL
No
Sponsors
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Romark Laboratories L.C.
INDUSTRY
Responsible Party
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Locations
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The Chappel Group Research
Kissimmee, Florida, United States
Clinical Trial Specialists, Inc.
Acworth, Georgia, United States
Centex Studies, Inc.
Lake Charles, Louisiana, United States
Centex Studies, Inc.
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RM08-3006
Identifier Type: -
Identifier Source: org_study_id
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