Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities

NCT04435314•Azidus Brasil

View on ClinicalTrials.gov

Summary

Detailed Description

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease. Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Informed consent from patient or legal representative.
•Subject of both genders (male and female not pregnant and not breastfeeding) aged 18 years or over;
•Subject that lives in a vulnerable community;
•Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
•Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
•Participant capable of understanding and fulfilling all activities planned for the study;
•In use of an acceptable method of contraception throughout the study.

Exclusion Criteria

•Participating in another RCT in the past 12 months;
•Positive PCR result for COVID-19 during screening;
•History of infection confirmed by SARS-CoV-2;
•Present symptoms suggestive of SARS-CoV-2 infection;
•Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
•* HIV or HTLV virus infection;
•* Chronic hepatitis C (HCV) treated with direct antiviral drugs;
•* Liver failure;
•* Severe renal failure, including dialysis;
•Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
+7 more criteria

Key Dates

Start Date

June 1, 2020

Primary Completion Date

August 1, 2020

Completion Date

August 1, 2020

Last Updated

October 28, 2022

Conditions

covid19

Interventions

Nitazoxanide

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 Post Exposure Prophylaxis of COVID-19

Inclusion Criteria

Exclusion Criteria

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