Covid 19Phase 3NCT06817096
Efficacy and Safety of Nitazoxanide 600 Mg in the Outpatient Treatment of COVID-19 and Influenza
A Phase 3 study of Covid 19 and Influenza, run by Azidus Brasil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
- 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
- Being tested
- Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
- Keywords
- nitazoxanide, outpatient treatment
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitazoxanide 600Mg Oral Tablet / placebo oral tabletDrug
1 tablet every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | take placebo orally, twice daily for 7 days. Receives: Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet |
| nitazoxanide | Experimental | take nitazoxanide 600 mg orally, twice daily for 7 days Receives: Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
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).
Measured: 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
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).
Measured: From enrollment to the end of treatment will last up to 60 days
Secondary outcomes (7)
Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19
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.
Measured: 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
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.
Measured: 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
The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding cognitive impairments observed between V6 and V8 in the following tests:
- MoCA
- TMT-A
- TMT-B
Measured: 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
The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding changes in spirometric parameters observed between V6 and V8:
- FVC
- FEV1
- FVC/FEV1
Measured: From enrollment to the end of treatment will last up to 60 days
Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications
The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the incidence of antibacterial medication prescriptions.
Measured: From enrollment to the end of treatment will last up to 60 days
Evaluation of the Effectiveness of Nitazoxanide in Preventing Hospitalization
The evaluation will be conducted by comparing the nitazoxanide and placebo groups regarding the incidence of hospitalization.
Measured: 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
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
Measured: From enrollment to the end of treatment will last up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Farmoquimica S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817096
- Sponsor's protocol ID
- FQMNita
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No