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

NCT ID: NCT06817096

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

placebo

take placebo orally, twice daily for 7 days.

Group Type: PLACEBO_COMPARATOR

Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

Intervention Type: DRUG

1 tablet every 12 hours

nitazoxanide

take nitazoxanide 600 mg orally, twice daily for 7 days

Group Type: EXPERIMENTAL

Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

Intervention Type: DRUG

1 tablet every 12 hours

Interventions

Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

1 tablet every 12 hours

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Farmoquimica S.A.

INDUSTRY

Sponsor Role: collaborator

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FQMNita

Identifier Type: -

Identifier Source: org_study_id