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

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ClinicalTrials.gov Identifier: NCT04412018
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
Amarin Corporation
HLS Therapeutics, Inc
Information provided by (Responsible Party):
Canadian Medical and Surgical Knowledge Translation Research Group

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 2, 2020
Last Update Posted Date June 5, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in differential count from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
  • Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2020)
  • 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)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: May 29, 2020)
  • Change in FLU-PRO scores from the screening visit to the Day 14 visit [ Time Frame: 14 days ]
  • World Health Organization Symptom Severity Scale [ Time Frame: 14 days ]
 
Descriptive Information
Brief Title  ICMJE An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19
Official Title  ICMJE An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Inflammatory Response
Intervention  ICMJE Drug: Icosapent ethyl
Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
Other Name: Vascepa
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Icosapent ethyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Subodh Verma, MD, PhD 1-416-864-5997 subodh.verma@unityhealth.to
Contact: Hwee Teoh, PhD postscripts@rogers.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04412018
Other Study ID Numbers  ICMJE Pro00043601
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Medical and Surgical Knowledge Translation Research Group
Study Sponsor  ICMJE Canadian Medical and Surgical Knowledge Translation Research Group
Collaborators  ICMJE
  • Amarin Corporation
  • HLS Therapeutics, Inc
Investigators  ICMJE
Principal Investigator: Subodh Verma, MD, PhD Canadian Medical and Surgical Knowledge Translation Research Group
PRS Account Canadian Medical and Surgical Knowledge Translation Research Group
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP