Prevention and Treatment of COVID19 With EPA in Subjects at Risk – IntErvention Trial - PREPARE-IT 1

Aug 29, 2021
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Amarin Pharma, Inc.
Date Presented:
08/29/2021
Date Published:
08/29/2021
Date Updated:
08/29/2021
Original Posted Date:
08/29/2021
References

Contribution To Literature:

The PREPARE-IT 1 trial showed that use of high-dose IPE for 60 days did not prevent incident SARS-CoV-2 infection among healthy participants who did not have prior known infection with or vaccination against COVID-19.

Description:

The goal of the trial was to assess the safety and efficacy of icosapent ethyl (IPE) on reducing infection rate among participants at high-risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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 60 days) (n = 850) or matching mineral oil placebo (n = 862).

  • Total screened: 4,244
  • Total number of enrollees: 1,712
  • Duration of follow-up: 60 days
  • Age: 40.5 years
  • Percentage female: 55%

Inclusion criteria:

  • ≥18 years
  • Any participant who is exposed to the public

Exclusion criteria:

  • Previous coronavirus disease 2019 (COVID-19) diagnosis
  • Positive pregnancy test at the time of study entry
  • Pregnancy or breastfeeding
  • Received one or more doses of any SARS-CoV-2 vaccine or who has an appointment to receive the vaccine within 60 days

Other salient features/characteristics:

  • Diabetes: 4%
  • Bronchial asthma: 7%
  • Hypercholesterolemia: 18%

Principal Findings:

The primary endpoint, SARS-CoV-2 positive at day 60, for IPE vs. placebo, was 7.9% vs. 7.1% (p = 0.58).

Secondary analyses for IPE vs. placebo:

  • Change in high-sensitivity C-reactive protein (hsCRP) from baseline: 0 vs. 0
  • Change in triglycerides from baseline: -2 vs. 7 mg/dl
  • Change in InFLUenza Patient-Reported Outcome (FLU-PRO) score from baseline: 0.01 vs. 0.3
  • Hospitalized for COVID-19: 0.1% vs. 0%

Interpretation:

The results of this trial indicate that use of high-dose IPE for 60 days did not prevent incident SARS-CoV-2 infection among healthy participants who did not have prior known infection with or vaccination against COVID-19. There was also no change in hsCRP in either arm, including in the placebo arm, which received mineral oil placebo. The higher dose of IPE (8 g/day) was well tolerated (REDUCE-IT trial used 4 g/day). PREPARE-IT 2 is examining the effect of IPE in SARS-CoV-2–positive nonhospitalized patients.

References:

Presented by Dr. Rafael Diaz at the European Society of Cardiology Virtual Congress, August 28, 2021.

Clinical Topics: COVID-19 Hub, Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Hypertriglyceridemia, Lipid Metabolism, Nonstatins

Keywords: ESC Congress, ESC21, COVID-19, C-Reactive Protein, Eicosapentaenoic Acid, Primary Prevention, SARS-CoV-2, Triglycerides, Vaccination


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