The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2-positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, and myalgia. Patients in the icosapent ethyl arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days in addition to standard care. Additionally, patients randomized to the nonactive arm received usual care. Baseline characteristics were analogous between the groups. The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined.
The VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while attaining its primary endpoint by demonstrating a 25% reduction in hsCRP with promising short-term safety and tolerability data using an icosapent ethyl loading dose. Administration also resulted in a considerable 52% decrease in the total patient-reported symptom outcome prevalence score compared with a 24% reduction in the standard-care group.
The researchers indicated that the limitations of this randomized study include the modest sample size, the unblinded nature of this trial, and the fact that the trial was not powered for clinical events. These results have not yet been published or reviewed by regulatory authorities. The researchers also noted that bigger follow-on clinical studies have commenced exploring the use of icosapent ethyl as a therapeutic option in COVID-19 settings, and these trials are projected to be completed in 2021.
In a press release, Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, principal investigator of VASCEPA COVID-19 CardioLink-9 and REDUCE-IT, stated, “This randomized trial represents the first human experience with a loading dose of icosapent ethyl and has demonstrated short-term safety and tolerability in a modest sample size. Regarding COVID-19, this study provides the first evidence of an early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients. The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19-related morbidity, though these results should be confirmed in a bigger trial.”
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