Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Farmoquimica S.A. | INDUSTRY |
Not provided
Not provided
Not provided
2. Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | take placebo orally, twice daily for 7 days. |
|
| nitazoxanide | Experimental | take nitazoxanide 600 mg orally, twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide 600Mg Oral Tablet / placebo oral tablet | Drug | 1 tablet every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | From enrollment to the end of treatment will last up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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:
| 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:
| 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. | 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. | 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 | From enrollment to the end of treatment will last up to 60 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |