Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 2

Conditions: Corona Virus Infection; Covid19; Pneumonia, Viral

Treatments: Drug: Nitazoxanide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04561219

30662420.0.1001.0008 (Other Identifier)

RBR-88bs9x (Other Identifier)

SARITA-1

Details and patient eligibility

About

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.

Full description

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),

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

Nitazoxanide

Experimental group

Description:

Patients received nitazoxanide 500mg 8/8hours, for 5 days.

Treatment:

Drug: Nitazoxanide

Placebo

Placebo Comparator group

Description:

Patients received placebo 500mg 8/8hours, for 5 days

Treatment:

Drug: Placebo