Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
SARITA-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional,
treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for
hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19)
Experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control
group: 250 patients received placebo 8/8 hours for 5 days.
Population: Patients with clinical symptoms of COVID-19: dyspnoea and/or fever and/or cough)
and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular
test by RT-PCR (Real Time polymerase chain reaction),
Drug: Nitazoxanide
Nitazoxanide 500mg three times a day for 5 days
Other Name: Array
Drug: Placebo
Placebo three times a day for 5 days
Inclusion Criteria:
- Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%],
admitted to hospital with COVID-19 symptoms associated with chest computed tomography
(CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for
SARS-CoV2 (RT-PCR)
- Age equal or superior to 18 years
- Non-pregnant women
- Willingness to receive study treatment
- Providing written and informed consent or the same consent signed by a family member
Exclusion Criteria:
- Impossibility to use oral medications
- History of severe liver disease (Child Pugh C class)
- Previous renal failure
- 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 drug
- Previous treatment with the study medication during the last 30 days
- Clinical suspicion of tuberculosis and bacterial pneumonia
Universidade Federal do Rio de Janeiro
Rio De Janeiro, Brazil