An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19

STATUS

Recruiting
participants needed

100
sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

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Updated on 19 February 2024

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fever

dyspnea

cough

pharyngitis

covid-19

myalgia

SARS

sore throat

icosapent ethyl

throat

acute respiratory syndrome (sars)

Summary

This is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that will enroll approximately 100 adult outpatients in Canada who have received a positive SARS-CoV-2 test result within the preceding 72 hours. Participants will be randomized (1:1) to receive either icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) or usual care. Blood samples will be collected to determine if icosapent ethyl use lowers circulating pro-inflammatory biomarkers.

Details

Condition	Inflammatory Response, Covid 19
Age	18years - 75years
Treatment	Icosapent ethyl
Clinical Study Identifier	NCT04412018
Sponsor	Canadian Medical and Surgical Knowledge Translation Research Group
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Positive local SARS-CoV-2 test result within the preceding 72 hours
	At least one of the following symptoms
	Fever
	Cough
	Sore throat
	Shortness of breath
	Myalgia
Exclusion Criteria
	Individuals currently participating in another interventional trial that will or may interfere with the primary outcome
	Hospitalized individuals
	Individuals who have a current medical condition for which life expectancy is less than 3 months
	Individuals with a history of acute end-organ injury (e.g. myocardial infarction, stroke, hospitalization for acute lung, liver or kidney disease) within the last month
	Individuals with active severe liver disease
	Individuals with a history of acute or chronic pancreatitis
	Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating
	Women of child-bearing potential who are not using at least one form of highly effective (hormonal contraceptives [e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants]; intrauterine device or intrauterine system; tubal ligation or whose partner has had a vasectomy) and one effective (barrier methods such male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method of contraception
	Individuals with a history of hemodynamic instability within past 72 hours including a systolic blood pressure of <95 mmHg and/or a diastolic blood pressure of <50 mmHg
	Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of IPE
	Individuals with any other condition which, in the opinion of the Investigator, would place the participant at increased risk, preclude obtaining voluntary consent or confound the objectives of study
	Individuals who are unable to swallow IPE capsules whole

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An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19