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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nitazoxanide

Subjects will receive nitazonanide 600 mg TID.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Subjects will receive nitazonanide 600 mg TID for 7 days

Placebo

Subjects will receive placebo TID.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive placebo TID for 7 days.

Interventions

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Nitazoxanide

Subjects will receive nitazonanide 600 mg TID for 7 days

Intervention Type DRUG

Placebo

Subjects will receive placebo TID for 7 days.

Intervention Type DRUG

Other Intervention Names

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Viranitta

Eligibility Criteria

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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;
* Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
* Participants who underwent treatment with antivirals and / or antiparasitic drugs in the last 30 days;
* Subject in antineoplastic treatment with chemotherapy or radiation therapy;
* Subject with severe autoimmune diseases in immunosuppression;
* Transplanted participants;
* Pregnant or lactating women;
* Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes