Prevention and Treatment of COVID-19 With EPA in Subjects at Risk – Intervention Trial 2 - PREPARE-IT 2
Contribution To Literature:
The PREPARE-IT 2 trial showed that use of IPE for 28 days did not reduce COVID-19–related hospitalizations or mortality among patients with nonhospitalized SARS-CoV-2 infection.
The goal of the trial was to assess the safety and efficacy of icosapent ethyl (IPE) on coronavirus disease 2019 (COVID-19)–related hospitalizations or mortality in patients with a positive diagnosis of COVID-19.
Patients were randomized in a 1:1 fashion to either IPE (4 g PO BID for 3 days, then 2 g BID for days 4-28) (n = 1,010) or matching placebo (n = 1,042).
- Total number of enrollees: 2,052
- Duration of follow-up: 28 days
- ≥40 years of age and
- COVID-19 diagnosis confirmed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (reverse transcription-polymerase chain reaction [RT-PCR] or rapid test) and
- No more than 7 days from the onset of symptoms and
- Without clear indication for hospitalization (1-2 in the World Health Organization COVID-19 Descriptive Score)
- Hospitalized patient or with a clear indication of hospitalization for COVID-19
- Pregnant or breastfeeding women
- Lack of access to adequate means of communication via the web
- Unable to provide informed consent
- Clear contraindication to IPE
- Known hypersensitivity to the study drug
- Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)
- Hemorrhagic diathesis
The primary endpoint, COVID-19–related hospitalization, for IPE vs. placebo, was 11.2% vs. 13.7% (hazard ratio 0.84, 95% CI 0.65-1.08; p = 0.17).
Secondary analyses for IPE vs. placebo:
- COVID-19 hospitalization or death: 5.4% vs. 6.8% (p = 0.18)
- New requirement for mechanical ventilation: 0.8% vs. 1.1% (p = 0.65)
- Hospital length of stay: 9 vs. 7 days (p = 0.01)
- Total events (nonfatal myocardial infarction or nonfatal stroke or death): 0.41 vs. 1.07 (p = 0.12)
- Mortality: 0.41 vs. 0.78 (p = 0.39)
The results of this trial indicate that the use of IPE for 28 days did not significantly reduce COVID-19–related hospitalizations or mortality among patients with nonhospitalized SARS-CoV-2 infection. PREPARE-IT 1 did not show a benefit with IPE among healthy participants who had a high risk of contracting COVID-19. PREPARE-IT 2 was underpowered, and any potential signal of benefit seen here would need to be confirmed in a much larger, adequately powered trial.
Presented by Dr. Rafael Diaz at the American Heart Association Virtual Annual Scientific Sessions (AHA 2021), November 15, 2021.
Clinical Topics: Anticoagulation Management, COVID-19 Hub, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins
Keywords: AHA21, AHA Annual Scientific Sessions, Anticoagulants, Coronavirus, COVID-19, Eicosapentaenoic Acid, Length of Stay, Primary Prevention, Respiration, Artificial, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2
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