A Phase 3 interventional study of Nitazoxanide 600Mg Oral Tablet / placebo oral tablet in Covid 19 and Influenza, sponsored by Azidus Brasil. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 340 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
take placebo orally, twice daily for 7 days.
Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
take nitazoxanide 600 mg orally, twice daily for 7 days
Drug: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
1 tablet every 12 hours
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).
Time frame: 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).
Time frame: From enrollment to the end of treatment will last up to 60 days
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.
Time frame: 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.
Time frame: 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: 1. MoCA 2. TMT-A 3. TMT-B
Time frame: 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: 1. FVC 2. FEV1 3. FVC/FEV1
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of treatment will last up to 60 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Azidus Brasil