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)

NCT04343248 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: RM08-3006
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19; Viral Respiratory Illnesses

Keywords

COVID-19; Viral Respiratory Illnesses

Outcome Measures

Primary Outcomes (2)

• 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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

  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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

  up to 6 weeks

Secondary Outcomes (3)

• Hospitalization Due to COVID-19 or Complications Thereof

  Up to 6 weeks

• Mortality Due to COVID-19 or Complications Thereof

  Up to 6 weeks

• Presence of Anti-SARS-CoV-2 at Weeks 6 or 8

  Up to 8 weeks

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks

Drug: Nitazoxanide; Dietary Supplement: Vitamin Super B-Complex

Placebo

PLACEBO COMPARATOR

Two placebo tablets orally twice daily for 6 weeks

Drug: Placebo; Dietary Supplement: Vitamin Super B-Complex

Interventions

Nitazoxanide DRUG

Nitazoxanide 600 mg administered orally twice daily for six weeks

Also known as: NTZ (nitazoxanide), NT-300

Nitazoxanide

Placebo DRUG

Placebo administered orally twice daily for six weeks

Placebo

Vitamin Super B-Complex DIETARY_SUPPLEMENT

Vitamin Super B-Complex administered orally twice daily to maintain the blind

Nitazoxanide; Placebo

Eligibility Criteria

• Age: 55 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (4)

The Chappel Group Research

Kissimmee, Florida, 34744, United States

Location

Clinical Trial Specialists, Inc.

Acworth, Georgia, 30101, United States

Location

Centex Studies, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

It was no longer possible to enroll eligible participants in the trial after vaccines were distributed to residents of long-term care facilities. Therefore, enrollment was terminated before the planned enrollment was completed. Study results are summarized descriptively, but no statistical analyses were performed.

Results Point of Contact

• Title: Sr. Director, Research Operations
• Organization: Romark, L.C.

jessica.fulgencio@romark.com

8132828544

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: May 12, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Locations

US (4)