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

NCT04412018 | Completed Phase 2 FDA Drug

• 1 other identifier: Pro00043601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  14 days

Secondary Outcomes (7)

• 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

Other Outcomes (2)

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

  14 days

• World Health Organization Symptom Severity Scale

  14 days

Study Arms (2)

Usual Care

NO INTERVENTION

Participants in this arm will continue with usual care

Icosapent Ethyl

EXPERIMENTAL

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

Interventions

Icosapent ethyl DRUG

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

Also known as: Vascepa

Icosapent Ethyl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Medical and Surgical Knowledge Translation Research Group: lead
• Amarin Corporation: collaborator
• HLS Therapeutics, Inc: collaborator

Study Sites (1)

North York Diagnostic and Cardiology Clinic

Toronto, Ontario, M6B 3H7, Canada

Location

Related Publications (1)

• 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.

  PMID: 34462732 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Subodh Verma, MD, PhD

  Canadian Medical and Surgical Knowledge Translation Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: June 4, 2020
• Primary Completion: November 6, 2020
• Study Completion: December 12, 2020
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)