Efficacy and Safety of Nitazoxanide for Post Exposure Pro... | NCT04788407

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

NCT04788407

Sponsor

Fundación Huésped

Status

Unknown status

Last Update Posted

Jul 2, 2021Actual

Enrollment

456Estimated

Phase

Phase 4

Conditions

Covid19
SARS-CoV-2 Infection
Households Contacts

Interventions

Nitazoxanide
Placebo

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

Mar 7, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2021

Last Update Posted Date

Jul 2, 2021Actual

Name	Class
Ministerio de Salud de Ciudad Autónoma de Buenos Aires	OTHER_GOV
Laboratorios Roemmers S.A.I.C.F.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

456Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitazoxanide	Experimental	Subjects will receive nitazoxanide 500 mg TID.	Drug: Nitazoxanide
Placebo	Placebo Comparator	Subjects will receive placebo TID.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	Subjects will receive nitazoxanide 500 mg TID for 7 days	Nitazoxanide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study	Proportion of participants with negative baseline PCR for SARS-CoV-2 who test positive for PCR on day 14 and / or seroconversion on day 28 after initiation of study medication.	28 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of adverse events (AE) and serious AE (SAE) related to research product.	Safety and adverse events (AEs).	28 days
Incidence of all causes of study drug withdrawal or discontinuation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar Sued, MD PHd	Contact	+54 11 4981-1855/7777	113	omar.sued@huesped.org.ar
Herman K Ludvik, MD	Contact	+54 11 4981-1855/7777	115	herman.ludvik@huesped.org.ar

Overall Officials

Name	Affiliation	Role
Omar Sued, MD PhMD	Fundacion Huesped.	Study Director
Herman K Ludvik, MD	Fundación Huésped	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Huésped.	Recruiting	Buenos Aires	Buenos Aires F.D.	C1204	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

to publish study results

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://www.huesped.org.ar/que-hacemos/ciencia/investigaciones-biomedicas/

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided