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

Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; SARS-CoV-2 Infection; Households Contacts
• Intervention / Treatment: Drug: Nitazoxanide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 456
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Omar Sued, MD PHd; Phone Number: 113 +54 11 4981-1855/7777; Email: omar.sued@huesped.org.ar
• Study Contact Backup: Name: Herman K Ludvik, MD; Phone Number: 115 +54 11 4981-1855/7777; Email: herman.ludvik@huesped.org.ar

Study Locations

• Argentina
  • Ciudad Autonoma De Buenos Aires
    • Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1204
      • Recruiting
      • Fundación Huésped.
      • Contact: Herman K Ludvik, MD
      • Principal Investigator: Omar Sued, MD PhMD
      • Sub-Investigator: Herman K. Ludvik, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitazoxanide; Subjects will receive nitazoxanide 500 mg TID.	Drug: Nitazoxanide; Subjects will receive nitazoxanide 500 mg TID for 7 days; Other Names: Nixoran
Placebo Comparator: Placebo; Subjects will receive placebo TID.	Drug: Placebo; Subjects will receive placebo TID for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Treatment adherence.	7 days

Collaborators and Investigators

• Sponsor: Fundación Huésped
• Collaborators: Ministerio de Salud de Ciudad Autónoma de Buenos Aires; Laboratorios Roemmers S.A.I.C.F.
• Investigators: Study Director: Omar Sued, MD PhMD, Fundación Huésped.; Principal Investigator: Herman K Ludvik, MD, Fundación Huésped

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections; Anti-Infective Agents; Antiparasitic Agents; Nitazoxanide
• Other Study ID Numbers: FH-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: to publish study results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No