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

Azidus

Status and phase: Not yet enrolling; Phase 3

Conditions: Covid 19; Influenza

Treatments: Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06817096

FQMNita

Details and patient eligibility

About

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

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

take placebo orally, twice daily for 7 days.

Treatment:

Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

nitazoxanide

Experimental group

Description:

take nitazoxanide 600 mg orally, twice daily for 7 days

Treatment:

Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet