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NCT Number: NCT06817096

Efficacy and Safety of Nitazoxanide 600 Mg 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

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitazoxanide 600Mg Oral Tablet / placebo oral tablet

Drug

1 tablet every 12 hours

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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:

    • MoCA
    • TMT-A
    • TMT-B

  4. 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:

    • FVC
    • FEV1
    • FVC/FEV1

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Collaborators

  • Farmoquimica S.A.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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