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

COVID-19 Clinical Trial

Official title:

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05157243
• Other study ID #: RM08-3010
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Age = 55 years (with or without comorbidities),

2. 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,

3. Chronic kidney disease,

4. Diabetes,

5. Immunosuppressive disease,

6. Currently receiving immunosuppressive treatment,

7. Cardiovascular disease (including congenital heart disease) or hypertension,

8. Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),

9. Sickle cell disease,

10. 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).

• Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of all protocol procedures.

Exclusion Criteria:

• Persons with any clinical signs or symptoms suggestive of severe systemic illness with COVID-19, including the following:

1. shortness of breath at rest

2. resting pulse =125 beats per minute

3. resting respiratory rate =30 breaths per minute

4. 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.

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

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

Drug:
• Placebo
Two matching placebo tablets administered orally with food twice daily for 5 days

Other:
• Standard of Care
Local standard of care for COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants with COVID-19-related hospitalization or death from any cause		Day 1 through Day 28
Other	Change in cytokine levels		Day 1 through Day 4
Primary	Proportion of participants progressing to severe COVID-19 or death from any cause		Day 1 through Day 28