Trial | NCT04412018  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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.
Study Started
Jun 04
2020
Primary Completion
Nov 06
2020
Study Completion
Dec 12
2020
Last Update
Dec 22
2021

Drug Icosapent ethyl

Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)

  • Other names: Vascepa

Usual Care No Intervention

Participants in this arm will continue with usual care

Icosapent Ethyl Experimental

Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)

Criteria 

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
No Results Posted