Trial | NCT04552483  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    392
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.
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).
Study Started
Jun 08
2020
Primary Completion
Aug 20
2020
Study Completion
Sep 05
2020
Last Update
Nov 03
2020

Drug Nitazoxanide

Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.

  • Other names: azox, annita, irose, tanisea, trinida, zoxany

Drug Placebo

Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.

Nitazoxanide Experimental

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

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted