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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Inflammatory Response

Intervention / Treatment
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* Drug: Icosapent ethyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants in this arm will continue with usual care | |
| Experimental: Icosapent Ethyl<br>Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) | Drug: Icosapent ethyl<br>* Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)<br>* Other names: Vascepa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in differential count from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit |  | 14 days | 
| Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit |  | 14 days |