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Not yet recruiting NCT06817096

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

Phase III Interventional Covid 19 Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitazoxanide 600Mg Oral Tablet / placebo oral tablet.
Who it may be relevant to
Registry conditions: Covid 19, Influenza. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug Nitazoxanide 600Mg Oral Tablet / placebo oral tablet
    1 tablet every 12 hours

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (7)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Evaluation of the Effectiveness of Nitazoxanide in Preventing 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 [Time frame: From enrollment to the end of treatment will last up to 60 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06817096 · FQMNita

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗