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

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-04-30

Brief Summary

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The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.

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Detailed Description

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Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days.

SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th.

Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.

Conditions

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Covid19 SARS-CoV-2 Infection Households Contacts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Cluster-Randomized, double-blind, placebo-controlled clinical trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nitazoxanide

Subjects will receive nitazoxanide 500 mg TID.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Subjects will receive nitazoxanide 500 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 nitazoxanide 500 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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Nixoran

Eligibility Criteria

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Inclusion Criteria

* Men and women over 18 and under 65.
* Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-2.
* Initiate study medication within 4 days from the last close contact with the index case.
* The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever\> 37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days.
* Informed consent from the patient or legal representative.

Exclusion Criteria

* History of infection confirmed by SARS-CoV-2.
* Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
* Have received any dose of nitazoxanide within 7 days prior to screening.
* Known hypersensitivity to any of the study medication components.
* Use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period.
* Inability to comply with study procedures.
* Current breastfeeding.
* Pregnancy.
* Intolerance or inability to take oral medication.
* History of severe liver disease (Child-Pugh B or C) and/or chronic kidney disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No