COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-4nr86m

Patricia Rocco

prmrocco@biof.ufrj.br

2020-08-24

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Universidade Federal do Rio de Janeiro-UFRJ

18

100

Brazil

No restriction on type of patients

0: No restriction on type of patients

0

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.

Phase 2

[{"arm_notes": "", "treatment_id": 888, "treatment_name": "Nitazoxanide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]