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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412018
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborators:
Amarin Corporation
HLS Therapeutics, Inc
Information provided by (Responsible Party):
Canadian Medical and Surgical Knowledge Translation Research Group

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.

Condition or disease Intervention/treatment Phase
COVID-19 Inflammatory Response Drug: Icosapent ethyl Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19)
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants in this arm will continue with usual care
Experimental: Icosapent Ethyl
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
Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
Other Name: Vascepa




Primary Outcome Measures :
  1. Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  2. Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  3. Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  4. Change in differential count from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  5. Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  6. Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  7. Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]

Other Outcome Measures:
  1. Change in FLU-PRO scores from the screening visit to the Day 14 visit [ Time Frame: 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)


  2. World Health Organization Symptom Severity Scale [ Time Frame: 14 days ]
    Response options will range from 0 to 6 with a higher value indicating a worse outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412018


Contacts
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Contact: Subodh Verma, MD, PhD 1-416-864-5997 subodh.verma@unityhealth.to
Contact: Hwee Teoh, PhD postscripts@rogers.com

Locations
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Canada, Ontario
North York Diagnostic and Cardiology Clinic Recruiting
Toronto, Ontario, Canada, M6B 3H7
Contact: Subodh Verma, MD, PhD         
Sponsors and Collaborators
Canadian Medical and Surgical Knowledge Translation Research Group
Amarin Corporation
HLS Therapeutics, Inc
Investigators
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Principal Investigator: Subodh Verma, MD, PhD Canadian Medical and Surgical Knowledge Translation Research Group
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Responsible Party: Canadian Medical and Surgical Knowledge Translation Research Group
ClinicalTrials.gov Identifier: NCT04412018    
Other Study ID Numbers: Pro00043601
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors