Coronavirus infection, unspecified / COVID-19
Conditions
Interventions
Patients diagnosed with COVID-19 will be randomly divided into 2 groups: experimental and control groups.
Experimental group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive nita
Drug
Sponsors
Universidade Federal do Rio de Janeiro-UFRJ
Universidade Federal do Rio de Janeiro-UFRJ
Complexo Hospitalar Municipal de São Caetano do Sul
Hospital de Transplantes Dr Euryclides de Jesus Zerbini Spdm - Associacao Paulista Para O Desenvolvimento da Medicina
Secretaria Municipal de Saúde de Bauru
Santa Casa de Misericórdia de Sorocaba
Secretaria Municipal de Saúde de Guarulhos
Hospital e Maternidade Therezinha de Jesus
Secretaria de Estado de Saúde do Distrito Federal
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on days 1 and 8; verified using the RT-PCR technique; quantified by the absolute and percentage change between the two days;Compare the hospital admission rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 8 days; verified by information actively collected from patients or family members; quantified by absolute number and percentage.;Compare the levels of inflammatory mediators: (interleukin [IL] -6, IL-1-beta, IL-8, interferon gamma, tumor necrosis factor [TNF] -alpha, monocyte chemoattract protein [MCP] -1) from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on days 3 and 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number and percentage between the two days.;Evaluate evolution of complete blood count, total and differential leukogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on days 3 and 8; verified by laboratory tests and expressed by the absolute number and percentage between the two days.;To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on days 3 and 8; verified by laboratory tests and expressed by the absolute number and percentage between the two days.;Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number and percentage.;Assess the rate of treatment discontinuation due to adverse events; verified by information | — |
Countries
Brazil
Contacts
Public ContactPatricia Rocco
Universidade Federal do Rio de Janeiro-UFRJ
Outcome results
None listed