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)

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 Overview

• Status: Completed
• Conditions: COVID-19; Inflammatory Response
• Intervention / Treatment: Drug: Icosapent ethyl

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants in this arm will continue with usual care
Experimental: Icosapent Ethyl; 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; Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days); Other Names: Vascepa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FLU-PRO scores from the screening visit to the Day 14 visit	Response options will be along one of the following formats: (i) 5-point Likert scale with answers ranging from (a) "Not at all" to "Very much" and (b) "Never" to "Always" (ii) Quantitative with answers ranging from "0 times" or "4 or more times" (iii) Binary response format (Yes or No)	14 days
World Health Organization Symptom Severity Scale	Response options will range from 0 to 6 with a higher value indicating a worse outcome	14 days

Collaborators and Investigators

• Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group
• Collaborators: HLS Therapeutics, Inc; Amarin Corporation
• Investigators: Principal Investigator: Subodh Verma, MD, PhD, Canadian Medical and Surgical Knowledge Translation Research Group

Publications and helpful links

General Publications

• Kosmopoulos A, Bhatt DL, Meglis G, Verma R, Pan Y, Quan A, Teoh H, Verma M, Jiao L, Wang R, Juliano RA, Kajil M, Kosiborod MN, Bari B, Berih AA, Aguilar M, Escano A, Leung A, Coelho I, Hibino M, Diaz R, Mason RP, Steg PG, Simon T, Go AS, Ambrosy AP, Choi R, Kushner AM, Leiter LA, Al-Omran M, Verma S, Mazer CD. A randomized trial of icosapent ethyl in ambulatory patients with COVID-19. iScience. 2021 Sep 24;24(9):103040. doi: 10.1016/j.isci.2021.103040. Epub 2021 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Platelet Aggregation Inhibitors; Lipid Regulating Agents; Eicosapentaenoic acid ethyl ester
• Other Study ID Numbers: Pro00043601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes