Effects of Icosapent Ethyl on Inflammatory Biomarkers in Individuals With COVID-19 - VASCEPA COVID-19 CardioLink-9

Dec 22, 2020
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Presenter/Author:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Amarin Pharma, Inc. and HLS Therapeutics, Inc.
Date Presented:
12/12/2020
Date Updated:
12/22/2020
Original Posted Date:
12/22/2020
References

Contribution To Literature:

The VASCEPA COVID-19 CardioLink-9 trial showed that use of IPE for 14 days significantly reduced hsCRP and symptoms between baseline and day 14 among outpatients who were symptomatic with COVID-19.

Description:

The goal of the trial was to assess the safety and efficacy of icosapent ethyl (IPE) on high-sensitivity C-reactive protein (hsCRP) and symptoms among outpatients with coronavirus 2019 (COVID-19).

Study Design

Patients were randomized in a 1:1 open-label fashion to either IPE (4 g PO BID for 3 days, then 2 g BID for 11 days; n = 50) or usual care (n = 50).

  • Total screened: 126
  • Total number of enrollees: 100
  • Duration of follow-up: 14 days
  • Age: 43 years
  • Percentage female: 55%

Inclusion criteria:

  • Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 72 hours
  • ≥1 of the following: fever, cough, sore throat, shortness of breath, and/or myalgia

Other salient features/characteristics:

  • Low-density lipoprotein cholesterol: 87 mg/dl
  • High-density lipoprotein cholesterol: 45 mg/dl
  • Triglycerides: 129 mg/dl

Principal Findings:

Change from baseline in high-sensitivity C-reactive protein (hsCRP) from baseline to day 14, in the patients randomized to IPE: 3.2 vs. 1.6 mg/L (p = 0.011). Comparison with usual care (p = 0.08).

Secondary analyses for IPE vs. usual care:

  • Change in D-dimer from baseline to day 14: 324.0 to 286.5 for IPE (p = 0.048), and 292.5 to 270.0 for usual care (p = 0.53; p for between-group comparison = 0.3)
  • Change in InFLUenza Patient-Reported Outcome (FLU-PRO) score from baseline to day 14: -0.17 vs. -0.1 (p = 0.003), mostly driven by body/systemic and chest/respiratory symptoms
  • Adverse events: 12% vs. 6%

Interpretation:

The results of this pilot trial indicate that the use of IPE for 14 days reduced hsCRP between baseline and day 14 among outpatients with COVID-19 randomized to IPE. It also showed significant improvements in patient-reported symptoms, as assessed by the FLU-PRO score. These results are promising and will need to be confirmed in a larger phase 3 placebo-controlled trial (PREPARE-IT).

References:

Presented by Dr. Deepak L. Bhatt at the National Lipid Association Virtual Scientific Sessions. December 12, 2020.

Clinical Topics: COVID-19 Hub, Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Hypertriglyceridemia, Lipid Metabolism, Nonstatins, Heart Failure and Cardiac Biomarkers

Keywords: Biomarkers, Cholesterol, HDL, Cholesterol, LDL, Cough, Coronavirus, COVID-19, C-Reactive Protein, Eicosapentaenoic Acid, Dyspnea, Fever, Fibrin Fibrinogen Degradation Products, Influenza, Human, Myalgia, Outpatients, Primary Prevention, severe acute respiratory syndrome coronavirus 2, Triglycerides


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