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

Canadian Medical and Surgical Knowledge Translation Research Group

Status and phase: Completed; Phase 2

Conditions: COVID-19; Inflammatory Response

Treatments: Drug: Icosapent ethyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04412018

Pro00043601

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Positive local SARS-CoV-2 test result within the preceding 72 hours

2. At least one of the following symptoms

   1. Fever
   2. Cough
   3. Sore throat
   4. Shortness of breath
   5. Myalgia

Exclusion criteria

1. Individuals currently participating in another interventional trial that will or may interfere with the primary outcome
2. Hospitalized individuals
3. Individuals who have a current medical condition for which life expectancy is less than 3 months
4. 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
5. Individuals with active severe liver disease
6. Individuals with a history of acute or chronic pancreatitis
7. Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating
8. 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
9. 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
10. Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of IPE
11. 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
12. Individuals who are unable to swallow IPE capsules whole

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants in this arm will continue with usual care

Icosapent Ethyl

Experimental group

Description:

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

Treatment:

Drug: Icosapent ethyl