NCT04552483

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

Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Covid19
• Coronavirus

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.
DRUG	Placebo	Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.

Timeline

• Start date: 2020-06-08
• Primary completion: 2020-08-20
• Completion: 2020-09-05
• First posted: 2020-09-17
• Last updated: 2020-11-03

Locations

1 site across 1 country: Brazil