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

Primary Purpose

COVID-19, Inflammatory Response

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Icosapent ethyl

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive local SARS-CoV-2 test result within the preceding 72 hours
At least one of the following symptoms
1. Fever
2. Cough
3. Sore throat
4. Shortness of breath
5. 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

Sites / Locations

North York Diagnostic and Cardiology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Icosapent Ethyl

Arm Description

Participants in this arm will continue with usual care

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

Outcomes

Primary Outcome Measures

Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit

Secondary Outcome Measures

Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit

Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit

Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit

Change in differential count from the randomization visit (Day 1) to the Day 14 visit

Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit

Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit

Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit

Full Information

NCT ID

NCT04412018

First Posted

May 29, 2020

Last Updated

December 21, 2021

Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Collaborators

Amarin Corporation, HLS Therapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04412018

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

June 4, 2020 (Actual)

Primary Completion Date

November 6, 2020 (Actual)

Study Completion Date

December 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Collaborators

Amarin Corporation, HLS Therapeutics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Inflammatory Response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Participants in this arm will continue with usual care

Arm Title

Icosapent Ethyl

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Icosapent ethyl

Other Intervention Name(s)

Vascepa

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in differential count from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Title

Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Change in FLU-PRO scores from the screening visit to the Day 14 visit

Description

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)

Time Frame

14 days

Title

World Health Organization Symptom Severity Scale

Description

Response options will range from 0 to 6 with a higher value indicating a worse outcome

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subodh Verma, MD, PhD

Organizational Affiliation

Canadian Medical and Surgical Knowledge Translation Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

North York Diagnostic and Cardiology Clinic

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6B 3H7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34462732

Citation

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.

Results Reference

derived

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

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