Status:
COMPLETED
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19
Lead Sponsor:
Canadian Medical and Surgical Knowledge Translation Research Group
Collaborating Sponsors:
Amarin Corporation
HLS Therapeutics, Inc
Conditions:
COVID-19
Inflammatory Response
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 resul...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04412018
Start Date
June 4 2020
End Date
December 12 2020
Last Update
December 22 2021
Active Locations (1)
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1
North York Diagnostic and Cardiology Clinic
Toronto, Ontario, Canada, M6B 3H7