Overview

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

Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación Huésped
Collaborators:
Laboratorios Roemmers S.A.I.C.F.
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
Treatments:
Nitazoxanide
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.