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

Phase 3

Not yet recruiting

• Conditions: Covid 19; Influenza
• Interventions: Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

• Registration Number: NCT06817096
• Lead Sponsor: Azidus Brasil

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nitazoxanide	Nitazoxanide 600Mg Oral Tablet / placebo oral tablet	take nitazoxanide 600 mg orally, twice daily for 7 days
placebo	Nitazoxanide 600Mg Oral Tablet / placebo oral tablet	take placebo orally, twice daily for 7 days.

Primary Outcome Measures

Name	Time	Method
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	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).
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	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).

Secondary Outcome Measures

Name	Time	Method
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	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, for participants who developed symptoms less than 24 hours before inclusion.
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	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, for participants who developed symptoms less than 24 hours before inclusion.
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	The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding cognitive impairments observed between V6 and V8 in the following tests: 1. MoCA; 2. TMT-A; 3. TMT-B
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	The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding changes in spirometric parameters observed between V6 and V8: 1. FVC; 2. FEV1; 3. FVC/FEV1
Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications	From enrollment to the end of treatment will last up to 60 days	The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the incidence of antibacterial medication prescriptions.
Evaluation of the Effectiveness of Nitazoxanide in Preventing Hospitalization	From enrollment to the end of treatment will last up to 60 days	The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the incidence of hospitalization.
Evaluation of the Safety of Nitazoxanide in Participants with COVID-19 or Influenza Under Outpatient Treatment	From enrollment to the end of treatment will last up to 60 days	The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the incidence and classification of treatment-emergent adverse events in terms of type, frequency, and severity.v