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

NCT04788407 | Unknown Phase 4

• 1 other identifier: FH-53
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV-2 Infection; Households Contacts

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Proportion of adverse events (AE) and serious AE (SAE) related to research product.

  28 days

• Incidence of all causes of study drug withdrawal or discontinuation.

  7 days

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

Subjects will receive nitazoxanide 500 mg TID.

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo TID.

Drug: Placebo

Interventions

Nitazoxanide DRUG

Subjects will receive nitazoxanide 500 mg TID for 7 days

Also known as: Nixoran

Nitazoxanide

Placebo DRUG

Subjects will receive placebo TID for 7 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Huésped: lead
• Ministerio de Salud de Ciudad Autónoma de Buenos Aires: collaborator
• Laboratorios Roemmers S.A.I.C.F.: collaborator

Study Sites (1)

Fundación Huésped.

Buenos Aires, Buenos Aires F.D., C1204, Argentina

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Omar Sued, MD PhMD

  Fundacion Huesped.

  STUDY DIRECTOR

• Herman K Ludvik, MD

  Fundación Huésped

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Sued, MD PHd

CONTACT

+54 11 4981-1855/7777; omar.sued@huesped.org.ar

Herman K Ludvik, MD

CONTACT

+54 11 4981-1855/7777; herman.ludvik@huesped.org.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

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

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 9, 2021
• Study Start: December 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)