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)

July 2, 2024 updated by: Romark Laboratories L.C.

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Kissimmee, Florida, United States, 34744
        • The Chappel Group Research
    • Georgia
      • Acworth, Georgia, United States, 30101
        • Clinical Trial Specialists, Inc.
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Centex Studies, Inc.
    • Texas
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Dietary supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Other Names:
  • NTZ (nitazoxanide)
  • NT-300
Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 6 weeks
Dietary supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Drug: Placebo
Placebo administered orally twice daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic Laboratory-confirmed COVID-19
Time Frame: 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.
up to 6 weeks
Symptomatic Laboratory-confirmed VRI
Time Frame: 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.
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization Due to COVID-19 or Complications Thereof
Time Frame: 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
Up to 6 weeks
Mortality Due to COVID-19 or Complications Thereof
Time Frame: 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.
Up to 6 weeks
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Time Frame: 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.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM08-3006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Vitamin Super B-Complex

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe