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Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19 | Clinical Trials | Clareo Health

COMPLETEDNA

Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.

NCT04348409•Azidus Brasil

View on ClinicalTrials.gov

Summary

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

Detailed Description

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19. The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo. Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent from patient or legal representative.
•2. Male or female, aged ≥ 18 years;
•3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
•4. Signs of respiratory failure requiring oxygen therapy
•5. Hospitalized for up to 36h with non-invasive ventilation
•6. Negative result for pregnancy test (if applicable).

Exclusion Criteria

•1. Participating in another RCT in the past 12 months;
•2. Known allergy to nitazoxanide
•3. Severely reduced LV function;
•4. Severely reduced renal function;
•5. Pregnancy or breast feeding;
•6. Use of hydroxychloroquine and/or azithromycin in the past 15 days;
•7. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products

Locations (3)

Hospital Vera Cruz

Campinas, São Paulo, Brazil

Centro de Genomas

São Paulo, Brazil

Hospital Emílio Ribas

São Paulo, Brazil

Key Dates

Start Date

May 25, 2020

Primary Completion Date

December 31, 2020

Completion Date

December 31, 2020

Last Updated

October 28, 2022

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Nitazoxanide Tablets

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Inclusion Criteria

Exclusion Criteria

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