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Trial - NCT04460651


Column Value
Trial registration number NCT04460651
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04460651

First author
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Andres Orlandini

Contact
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

aorlandinimd@eclainternational.org

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-07

Recruitment status
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

(a) prevention arm: inclusion criteria: 18 years of age or older and any subject that is circulating and exposed to the public

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

previously diagnosed with covid-19 positive pregnancy test at the time of study entry in potentially fertile women pregnant or breastfeeding women subject who has received one or more doses of any vaccine for sars-cov-2 or who is scheduled to be vaccinated within the next 60 days unable to provide informed consent clear contraindication to epa known hypersensitivity to the study drug administration of a drug with anticoagulant effects (antiplatelet agents are allowed) hemorrhagic diathesis (b) treatment arm: inclusion criteria: 40 years of age or older and covid 19 diagnosis confirmed with sars cov-2 test (rt-pcr) and no more than 7 days from the onset of symptoms and without clear indication for hospitalization (1-2 in the who covid-19 descriptive score).

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Estudios Clínicos Latino América

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Argentina

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

4093

primary outcome
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

(A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60.;(B) Treatment Arm: COVID 19 related hospitalization (indication for hospitalization per the blinded investigator or actual hospitalization) or death assessed up to 28 days

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 622, "treatment_name": "Icosapent ethyl", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]