Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

NCT05157243 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: RM08-3010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.

Conditions

COVID-19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Proportion of participants progressing to severe COVID-19 or death from any cause

  Day 1 through Day 28

Other Outcomes (2)

• Proportion of participants with COVID-19-related hospitalization or death from any cause

  Day 1 through Day 28

• Change in cytokine levels

  Day 1 through Day 4

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

Nitazoxanide 300 mg extended release tablets

Drug: Nitazoxanide; Dietary Supplement: Vitamin Super-B Complex; Other: Standard of Care

Placebo

PLACEBO COMPARATOR

Placebo tablets

Dietary Supplement: Vitamin Super-B Complex; Drug: Placebo; Other: Standard of Care

Interventions

Nitazoxanide DRUG

Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days

Also known as: NTZ, NT-300

Nitazoxanide

Vitamin Super-B Complex DIETARY_SUPPLEMENT

Vitamin Super B-Complex administered orally twice daily for 5 days to maintain the blind

Nitazoxanide; Placebo

Placebo DRUG

Two matching placebo tablets administered orally with food twice daily for 5 days

Placebo

Standard of Care OTHER

Local standard of care for COVID-19

Also known as: SOC

Nitazoxanide; Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 12 years of age
• At high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
• Age ≥ 55 years (with or without comorbidities),
• Body mass index (BMI) ≥30 kg/m² if ≥ 18 years of age or BMI ≥85th percentile for age and gender based on CDC growth charts,
• Chronic kidney disease,
• Diabetes,
• Immunosuppressive disease,
• Currently receiving immunosuppressive treatment,
• Cardiovascular disease (including congenital heart disease) or hypertension,
• Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
• Sickle cell disease,
• Neurodevelopmental disorders or other conditions that confer medical complexity.
• Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
• Presence of symptoms consistent with mild or moderate COVID-19 in the judgment of the Investigator.
• Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).

You may not qualify if:

• Persons with any clinical signs or symptoms suggestive of severe systemic illness with COVID-19, including the following:
• shortness of breath at rest
• resting pulse ≥125 beats per minute
• resting respiratory rate ≥30 breaths per minute
• Oxygen saturation ≤ 93% on room air at sea level
• Immunocompetent persons who have been fully vaccinated for SARS-CoV-2, defined as having received all expected vaccine doses for a 2-dose or single-dose series at least two weeks prior to onset of symptoms.
• Females of childbearing potential who are either pregnant or sexually active without the use of birth control.
• Subjects residing in the same household with another subject participating in the study.
• Treatment with any investigational drug or vaccine therapy within 30 days prior to screening.
• Receipt of monoclonal antibody therapy for COVID-19 within the preceding 90 days.
• Receipt of any dose of NTZ within seven days prior to screening.
• Known sensitivity to NTZ or any of the excipients comprising the study medication.
• Subjects unable to swallow oral tablets or capsules.
• Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
• Subjects likely or expected to require hospitalization unrelated to COVID-19 during the study period.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide; Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Model Details: Eligible participants will be randomized 1:1 to receive 600mg NTZ or placebo twice daily for 5 days.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 14, 2021
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09