<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412018</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00043601</org_study_id>
    <nct_id>NCT04412018</nct_id>
  </id_info>
  <brief_title>An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19</brief_title>
  <official_title>An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Medical and Surgical Knowledge Translation Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amarin Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HLS Therapeutics, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Medical and Surgical Knowledge Translation Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that&#xD;
      will enroll approximately 100 adult outpatients in Canada who have received a positive&#xD;
      SARS-CoV-2 test result within the preceding 72 hours. Participants will be randomized (1:1)&#xD;
      to receive either icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11&#xD;
      days) or usual care. Blood samples will be collected to determine if icosapent ethyl use&#xD;
      lowers circulating pro-inflammatory biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">December 12, 2020</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in differential count from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in FLU-PRO scores from the screening visit to the Day 14 visit</measure>
    <time_frame>14 days</time_frame>
    <description>Response options will be along one of the following formats:&#xD;
(i) 5-point Likert scale with answers ranging from (a) &quot;Not at all&quot; to &quot;Very much&quot; and (b) &quot;Never&quot; to &quot;Always&quot; (ii) Quantitative with answers ranging from &quot;0 times&quot; or &quot;4 or more times&quot; (iii) Binary response format (Yes or No)</description>
  </other_outcome>
  <other_outcome>
    <measure>World Health Organization Symptom Severity Scale</measure>
    <time_frame>14 days</time_frame>
    <description>Response options will range from 0 to 6 with a higher value indicating a worse outcome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>COVID-19</condition>
  <condition>Inflammatory Response</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm will continue with usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Icosapent Ethyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icosapent ethyl</intervention_name>
    <description>Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)</description>
    <arm_group_label>Icosapent Ethyl</arm_group_label>
    <other_name>Vascepa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Positive local SARS-CoV-2 test result within the preceding 72 hours&#xD;
&#xD;
          2. At least one of the following symptoms&#xD;
&#xD;
               1. Fever&#xD;
&#xD;
               2. Cough&#xD;
&#xD;
               3. Sore throat&#xD;
&#xD;
               4. Shortness of breath&#xD;
&#xD;
               5. Myalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals currently participating in another interventional trial that will or may&#xD;
             interfere with the primary outcome&#xD;
&#xD;
          2. Hospitalized individuals&#xD;
&#xD;
          3. Individuals who have a current medical condition for which life expectancy is less&#xD;
             than 3 months&#xD;
&#xD;
          4. Individuals with a history of acute end-organ injury (e.g. myocardial infarction,&#xD;
             stroke, hospitalization for acute lung, liver or kidney disease) within the last month&#xD;
&#xD;
          5. Individuals with active severe liver disease&#xD;
&#xD;
          6. Individuals with a history of acute or chronic pancreatitis&#xD;
&#xD;
          7. Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are&#xD;
             lactating&#xD;
&#xD;
          8. Women of child-bearing potential who are not using at least one form of highly&#xD;
             effective (hormonal contraceptives [e.g. combined oral contraceptives, patch, vaginal&#xD;
             ring, injectables, and implants]; intrauterine device or intrauterine system; tubal&#xD;
             ligation or whose partner has had a vasectomy) and one effective (barrier methods such&#xD;
             male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method&#xD;
             of contraception&#xD;
&#xD;
          9. Individuals with a history of hemodynamic instability within past 72 hours including a&#xD;
             systolic blood pressure of &lt;95 mmHg and/or a diastolic blood pressure of &lt;50 mmHg&#xD;
&#xD;
         10. Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of&#xD;
             IPE&#xD;
&#xD;
         11. Individuals with any other condition which, in the opinion of the Investigator, would&#xD;
             place the participant at increased risk, preclude obtaining voluntary consent or&#xD;
             confound the objectives of study&#xD;
&#xD;
         12. Individuals who are unable to swallow IPE capsules whole&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Subodh Verma, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canadian Medical and Surgical Knowledge Translation Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North York Diagnostic and Cardiology Clinic</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6B 3H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eicosapentaenoic acid ethyl ester</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 12, 2022</submitted>
    <returned>February 17, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412018
org study id: Pro00043601
nct id: NCT04412018
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in differential count from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit
time frame: 14 days
measure: Change in FLU-PRO scores from the screening visit to the Day 14 visit
time frame: 14 days
description: 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)
measure: World Health Organization Symptom Severity Scale
time frame: 14 days
description: Response options will range from 0 to 6 with a higher value indicating a worse outcome
arm group label: Usual Care
arm group type: No Intervention
description: Participants in this arm will continue with usual care
arm group label: Icosapent Ethyl
arm group type: Experimental
description: Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
intervention type: Drug
intervention name: Icosapent ethyl
description: Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
arm group label: Icosapent Ethyl
other name: Vascepa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Subodh Verma, MD, PhD
role: Principal Investigator
affiliation: Canadian Medical and Surgical Knowledge Translation Research Group
facility: 
country: Canada
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Eicosapentaenoic acid ethyl ester
sharing ipd: No
submitted: February 12, 2022
returned: February 17, 2022