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

February 6, 2025 updated by: Azidus Brasil

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
take placebo orally, twice daily for 7 days.
Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
1 tablet every 12 hours
Experimental: nitazoxanide
take nitazoxanide 600 mg orally, twice daily for 7 days
Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
1 tablet every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
Time Frame: 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).
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
Time Frame: 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).
From enrollment to the end of treatment will last up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
From enrollment to the end of treatment will last up to 60 days
Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications
Time Frame: 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.
From enrollment to the end of treatment will last up to 60 days
Evaluation of the Effectiveness of Nitazoxanide in Preventing Hospitalization
Time Frame: 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.
From enrollment to the end of treatment will last up to 60 days
Evaluation of the Safety of Nitazoxanide in Participants with COVID-19 or Influenza Under Outpatient Treatment
Time Frame: 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
From enrollment to the end of treatment will last up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Collaborators

Farmoquimica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FQMNita

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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