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Completed

NCT Number: NCT04412018

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Inflammatory Response Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

North York Diagnostic and Cardiology Clinic

Toronto, Ontario, M6B 3H7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Icosapent Ethyl

Drug

Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)

Other names: Vascepa

Primary outcomes

  1. Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit

    Time frame: 14 days

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Other

Collaborators

  • Amarin Corporation
  • HLS Therapeutics, Inc

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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