Clinical trial NCT04412018: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Inflammatory Response
Lead sponsor: Canadian Medical and Surgical Knowledge Translation Research Group
Sponsor class: OTHER
Collaborators: name: Amarin Corporation
name: HLS Therapeutics, Inc
First posted: 2020-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
Secondary outcomes:
measure: Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in differential count from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
measure: Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit
timeFrame: 14 days
Other outcomes:
measure: Change in FLU-PRO scores from the screening visit to the Day 14 visit
timeFrame: 14 days
measure: World Health Organization Symptom Severity Scale
timeFrame: 14 days
Locations:
city: Toronto
country: Canada
facility: North York Diagnostic and Cardiology Clinic
state: Ontario
Study officials:
affiliation: Canadian Medical and Surgical Knowledge Translation Research Group
name: Subodh Verma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.