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Trial - NCT04788407


Column Value
Trial registration number NCT04788407
Full text link
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04788407

First author
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Omar Sued, MD PHd

Contact
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

omar.sued@huesped.org.ar

Registration date
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-09

Recruitment status
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Fundación Huésped

Inclusion age min
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Argentina

Type of patients
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

456

primary outcome
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study

Notes
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 888, "treatment_name": "Nitazoxanide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]