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

Phase 3Not Yet RecruitingNCT06817096

Azidus Brasil340 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

340

Conditions

Covid 19 Influenza

Interventions

Nitazoxanide 600Mg Oral Tablet / placebo oral tabletDRUG

1 tablet every 12 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the end of treatment will last up to 60 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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