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)

Phase 3

Terminated

• Conditions: COVID-19; Viral Respiratory Illnesses
• Interventions: Drug: Placebo; Drug: Nitazoxanide; Dietary Supplement: Vitamin Super B-Complex

• Registration Number: NCT04343248
• Lead Sponsor: Romark Laboratories L.C.

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.

Study Timeline

• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Study Start: 2020-05-12
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Disposition First Submitted: 2022-06-28
• Results First Submitted: 2024-06-11
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Results First Posted: 2024-07-08
• Disposition First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitazoxanide	Vitamin Super B-Complex	Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Placebo	Placebo	Two placebo tablets orally twice daily for 6 weeks
Placebo	Vitamin Super B-Complex	Two placebo tablets orally twice daily for 6 weeks
Nitazoxanide	Nitazoxanide	Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Symptomatic Laboratory-confirmed COVID-19	up to 6 weeks	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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Symptomatic Laboratory-confirmed VRI	up to 6 weeks	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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

Secondary Outcome Measures

Name	Time	Method
Hospitalization Due to COVID-19 or Complications Thereof	Up to 6 weeks	Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8	Up to 8 weeks	Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Mortality Due to COVID-19 or Complications Thereof	Up to 6 weeks	Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

Trial Locations

Locations (3)

The Chappel Group Research; 🇺🇸 Kissimmee, Florida, United States

Clinical Trial Specialists, Inc.; 🇺🇸 Acworth, Georgia, United States

Centex Studies, Inc.; 🇺🇸 Houston, Texas, United States