Efficacy and Safety of Nitazoxanide 600 Mg in the Outpatient Treatment of COVID-19 and Influenza

NCT06817096 | Not Yet Recruiting Phase 3

• 1 other identifier: FQMNita
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

2\. Participants will:

• Take nitazoxanide 600mg (or placebo) orally twice daily for 7 days, for a total of 14 doses.
• Visit the clinic on the 7th day of treatment for a check-up and safety tests.
• Keep a diary of their symptoms and other medications used

Conditions

Covid 19; Influenza

Keywords

nitazoxanide; outpatient treatment

Outcome Measures

Primary Outcomes (2)

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19

  The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the time to symptom resolution (fever, cough, runny nose, nasal congestion, sore throat, fatigue, headache, muscle pain, sweating, or chills) from inclusion until fever is absent and the other signs and symptoms reach a score\* of 1 or 0. \*Scores will be classified from 0 to 3, as follows: absent (0), mild (1), moderate (2), or severe (3), according to the Influenza-like Illness Signs and Symptoms Scale (ILISSS).

  From enrollment to the end of treatment will last up to 60 days

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of Influenza

  The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the time to symptom resolution (fever, cough, runny nose, nasal congestion, sore throat, fatigue, headache, muscle pain, sweating, or chills) from inclusion until fever is absent and the other signs and symptoms reach a score\* of 1 or 0. \*Scores will be classified from 0 to 3, as follows: absent (0), mild (1), moderate (2), or severe (3), according to the Influenza-like Illness Signs and Symptoms Scale (ILISSS).

  From enrollment to the end of treatment will last up to 60 days

Secondary Outcomes (7)

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19

  From enrollment to the end of treatment will last up to 60 days

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of Influenza

  From enrollment to the end of treatment will last up to 60 days

• Evaluation of the Protective Effect of Nitazoxanide on the Development of Cognitive Changes Resulting from COVID-19

  From enrollment to the end of treatment will last up to 60 days

• Evaluation of the Protective Effect of Nitazoxanide on the Development of Pulmonary Dysfunction Resulting from COVID-19

  From enrollment to the end of treatment will last up to 60 days

• Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications

  From enrollment to the end of treatment will last up to 60 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

take placebo orally, twice daily for 7 days.

Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

nitazoxanide

EXPERIMENTAL

take nitazoxanide 600 mg orally, twice daily for 7 days

Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

Interventions

Nitazoxanide 600Mg Oral Tablet / placebo oral tablet DRUG

1 tablet every 12 hours

nitazoxanide; placebo

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form;
• Male or female;
• Age ≥ 18 years;
• COVID-19 or influenza diagnosed by rapid test, with symptom onset less than 48 hours ago;
• Clinical condition compatible with outpatient treatment.

You may not qualify if:

• Known hypersensitivity to nitazoxanide;
• History of cardiomyopathies, hepatopathies, or nephropathies;
• Antineoplastic treatment with chemotherapy or radiotherapy;
• Severe autoimmune diseases with immunosuppression;
• Transplant recipients;
• Any uncompensated systemic disease at the investigator's discretion;
• Participation in clinical studies in the last 12 months;
• Pregnant or breastfeeding individuals;
• Suspected bacterial coinfection or prescription of antibiotic therapy at enrollment;
• Diagnosis of neurological disease (traumatic brain injury, stroke, Parkinson's disease, Alzheimer's disease, other dementias);
• Diagnosis of developmental disorder (ADHD, ASD, learning disabilities, intellectual disability, Rett syndrome);
• Significant hearing or vision impairment.

Sponsors & Collaborators

• Azidus Brasil: lead
• Farmoquimica S.A.: collaborator

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

nitazoxanide; Tablets

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; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02