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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment will last up to 60 days]

Вторичные конечные точки (7)

• Evaluation of the Effectiveness of Nitazoxanide in the Outpatient Treatment of COVID-19 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment will last up to 60 days]
• Evaluation of the Effectiveness of Nitazoxanide in Preventing Bacterial Complications [Срок оценки: From enrollment to the end of treatment will last up to 60 days]
• Evaluation of the Effectiveness of Nitazoxanide in Preventing Hospitalization [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment will last up to 60 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06817096 · FQMNita

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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