Effects of Early Use of Nitazoxanide in Patients With COVID-19

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 2

Conditions: Covid19; Coronavirus

Treatments: Drug: Nitazoxanide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04552483

32258920.0.1001.5257 (Other Identifier)

SARITA-2

RBR-4nr86m (Other Identifier)

Details and patient eligibility

About

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.

Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.

Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.

Full description

SARITA-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the COVID-19 (Coronavirus Disease-19).

Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients received placebo 8/8 hours for 5 days.

Population: 392 Patients with COVID-19, confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.

Calculation of the sample size was based on a previous study which demonstrated that 78% of Covid-19 patients in group 4 (Hospitalized without oxygen therapy), according to the WHO ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 In the present trial, patients were classified as group 2 (Symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. Thus, assuming an 11% increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo, we would need approximately 196 patients per experimental group, admitting a beta error of 15% and alpha error of 5%, for a total n of 392 patients. Calculation of the sample size was done by G*Power 3.1.9.2 (Universität Düsseldorf, Düsseldorf, Germany).

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough 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

• 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
• 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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392 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