Status:
UNKNOWN
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts
Lead Sponsor:
Fundación Huésped
Collaborating Sponsors:
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
Laboratorios Roemmers S.A.I.C.F.
Conditions:
Covid19
SARS-CoV-2 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 hou...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT04788407
Start Date
December 1 2020
End Date
April 30 2022
Last Update
July 2 2021
Active Locations (1)
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1
Fundación Huésped.
Buenos Aires, Buenos Aires F.D., Argentina, C1204