Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts (PENTZ)
Primary Purpose
Covid19, SARS-CoV-2 Infection, Households Contacts
Status
Unknown status
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
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.
Sites / Locations
- Fundación Huésped.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitazoxanide
Placebo
Arm Description
Subjects will receive nitazoxanide 500 mg TID.
Subjects will receive placebo TID.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of adverse events (AE) and serious AE (SAE) related to research product.
Safety and adverse events (AEs).
Incidence of all causes of study drug withdrawal or discontinuation.
Treatment adherence.
Full Information
NCT ID
NCT04788407
First Posted
March 7, 2021
Last Updated
July 1, 2021
Sponsor
Fundación Huésped
Collaborators
Ministerio de Salud de Ciudad Autónoma de Buenos Aires, Laboratorios Roemmers S.A.I.C.F.
1. Study Identification
Unique Protocol Identification Number
NCT04788407
Brief Title
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts
Acronym
PENTZ
Official Title
Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Huésped
Collaborators
Ministerio de Salud de Ciudad Autónoma de Buenos Aires, Laboratorios Roemmers S.A.I.C.F.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV-2 Infection, Households Contacts
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Cluster-Randomized, double-blind, placebo-controlled clinical trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
456 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Experimental
Arm Description
Subjects will receive nitazoxanide 500 mg TID.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo TID.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Nixoran
Intervention Description
Subjects will receive nitazoxanide 500 mg TID for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo TID for 7 days
Primary Outcome Measure Information:
Title
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of adverse events (AE) and serious AE (SAE) related to research product.
Description
Safety and adverse events (AEs).
Time Frame
28 days
Title
Incidence of all causes of study drug withdrawal or discontinuation.
Description
Treatment adherence.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Sued, MD PHd
Phone
+54 11 4981-1855/7777
Ext
113
Email
omar.sued@huesped.org.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Herman K Ludvik, MD
Phone
+54 11 4981-1855/7777
Ext
115
Email
herman.ludvik@huesped.org.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Sued, MD PhMD
Organizational Affiliation
Fundacion Huesped.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Herman K Ludvik, MD
Organizational Affiliation
Fundación Huésped
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Huésped.
City
Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
C1204
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herman K Ludvik, MD
First Name & Middle Initial & Last Name & Degree
Omar Sued, MD PhMD
First Name & Middle Initial & Last Name & Degree
Herman K. Ludvik, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
to publish study results
IPD Sharing URL
https://www.huesped.org.ar/que-hacemos/ciencia/investigaciones-biomedicas/
Learn more about this trial
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts
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