Clinical trial NCT06817096: Efficacy and Safety of Nitazoxanide 600 Mg in the Outpatient Treatment of COVID-19 and Influenza
Official title: Phase 3, Multicenter, Parallel, Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Nitazoxanide 600 Mg Administered Twice Daily, in the Outpatient Treatment of COVID-19 and Influenza
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Covid 19
Influenza
Keywords: nitazoxanide
outpatient treatment
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Farmoquimica S.A.
First posted: 2025-02-10
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of Influenza
timeFrame: From enrollment to the end of treatment will last up to 60 days
Secondary outcomes:
measure: Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of Influenza
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Protective Effect of Nitazoxanide on the Development of Cognitive Changes Resulting from COVID-19
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Protective Effect of Nitazoxanide on the Development of Pulmonary Dysfunction Resulting from COVID-19
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Effectiveness of Nitazoxanide in Preventing Hospitalization
timeFrame: From enrollment to the end of treatment will last up to 60 days
measure: Evaluation of the Safety of Nitazoxanide in Participants with COVID-19 or Influenza Under Outpatient Treatment
timeFrame: From enrollment to the end of treatment will last up to 60 days
Other outcomes:
Locations:
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