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Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19

Phase 2
Recruiting
Conditions
Coronavirus infection, unspecified / COVID-19
B34.2
Registration Number
RBR-4nr86m
Lead Sponsor
niversidade Federal do Rio de Janeiro-UFRJ
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Will be included in the study of patients of both genders who meet all of the following requirements: clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or drought and / or fatigue), beginning 1 to 3 days before inclusion in the study; age equal or superior to 18 years; willingness to receive study treatment; providing written and informed consent or the same consent signed by a family member.

Exclusion Criteria

Individuals who meet at least one of the following criteria will be excluded from the study: negative result of RT-PCR for SARS-COV2 collected on admission; impossibility to use oral medications; history of severe liver disease (Child Pugh C class); previous renal failure: patients undergoing dialysis; severe heart failure (NYHA 3 or 4); COPD (GOLD 3 and 4); neoplasia in the last 5 years; known autoimmune disease; individuals with known hypersensitivity to study drugs; previous treatment with the study medication during the last 30 days; clinical suspicion of tuberculosis and bacterial pneumonia.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br>;Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br>;Reduction in the duration of fatigue of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br>
Secondary Outcome Measures
NameTimeMethod
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