COVID-19, Inflammatory Response
Conditions
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.
Interventions
DRUGIcosapent ethyl
Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
Sponsors
Amarin Corporation
HLS Therapeutics, Inc
Canadian Medical and Surgical Knowledge Translation Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Change in systemic immune-inflammation index 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
| Measure | Time frame | Description |
|---|---|---|
| Change in FLU-PRO scores from the screening visit to the Day 14 visit | 14 days | 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) |
| World Health Organization Symptom Severity Scale | 14 days | Response options will range from 0 to 6 with a higher value indicating a worse outcome |
Countries
Canada
Outcome results
None listed