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Trial - NCT04894721


Column Value
Trial registration number NCT04894721
Full text link
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04894721

First author
Last imported at : Dec. 9, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Maria Peral, Ph.D.

Contact
Last imported at : Dec. 9, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

mperal@fm.unt.edu.ar

Registration date
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-20

Recruitment status
Last imported at : Dec. 9, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 22, 2021, 12:32 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 : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - over 18 years either sex - women of childbearing age with a negative pregnancy test - in close contact group or epidemiological nexus of a positive covid-19 case - able to understand and grant informed consent - real-time - polymerase chain reaction test with a negative result

Exclusion criteria
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- known hypersensitivity or allergy to any component of the drug under evaluation - age under 18 years - use of immunosuppressants (including systemic corticosteroids) in the last 30 days - pregnant or lactating - patients with other acute infectious diseases - patients with autoimmune disease and/or chronic decompensated diseases - who have received a vaccine for covid-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another covid-19 prophylaxis study

Number of arms
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Ministry of Public Health, Argentina

Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

60

Countries
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Argentina

Type of patients
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 9, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

172

primary outcome
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Number of subjects who were diagnosed with COVID-19 in EG and CG (Negative polymerase chain reaction - real-time).

Notes
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : May 22, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]