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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412018
• Other study ID #: Pro00043601
• Status: Completed
• Phase: Phase 2
• Start date: June 4, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: December 2021
• Source: Canadian Medical and Surgical Knowledge Translation Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Inflammatory Response

Intervention

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

Locations

Country	Name	City	State
Canada	North York Diagnostic and Cardiology Clinic	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Medical and Surgical Knowledge Translation Research Group	Amarin Corporation, HLS Therapeutics, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	World Health Organization Symptom Severity Scale	Response options will range from 0 to 6 with a higher value indicating a worse outcome	14 days
Primary	Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in differential count from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit		14 days
Secondary	Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit		14 days