Last updated: July 1, 2021
Sponsor: Fundación Huésped
Overall Status: Active - Recruiting
Phase
4
Condition
Corona Virus
Treatment
N/AClinical Study ID
NCT04788407
FH-53
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 indexcase.
- 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 thestudy and from previous 14 days.
- Informed consent from the patient or legal representative.
Exclusion
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 toscreening, 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 Design
Total Participants: 456
Study Start date:
December 01, 2020
Estimated Completion Date:
April 30, 2022
Study Description
Connect with a study center
Fundación Huésped.
Buenos Aires, Ciudad Autonoma De Buenos Aires C1204
ArgentinaActive - Recruiting
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