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

NCT ID: NCT04412018

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2020-12-12

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.

Conditions

COVID-19; Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants in this arm will continue with usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Icosapent ethyl

Intervention Type: DRUG

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

Interventions

Icosapent ethyl

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

Intervention Type: DRUG

Other Intervention Names

Vascepa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amarin Corporation

UNKNOWN

Sponsor Role: collaborator

HLS Therapeutics, Inc

UNKNOWN

Sponsor Role: collaborator

Canadian Medical and Surgical Knowledge Translation Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subodh Verma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Canadian Medical and Surgical Knowledge Translation Research Group

Locations

North York Diagnostic and Cardiology Clinic

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34462732 (View on PubMed)

Other Identifiers

Pro00043601

Identifier Type: -

Identifier Source: org_study_id