A Randomized Trial of Icosapent Ethyl in Ambulatory Patients with COVID-19

Kosmopoulos, Andrew; Bhatt, Deepak L.; Meglis, Gus; Verma, Raj; Pan, Yi; Quan, Adrian; Teoh, Hwee; Verma, Maya; Jiao, Lixia; Wang, Robert; Juliano, Rebecca A.; Kajil, Mahesh; Kosiborod, Mikhail N.; Bari, Basel; Berih, Abdullahi A.; Aguilar, Mallory; Escano, Antonnette; Leung, Andrew; Coelho, Idelta; Hibino, Makoto; Díaz, Rafael; Mason, R. Preston; Steg, Ph. Gabriel; Simon, Tabassome; Go, Alan S.; Ambrosy, Andrew P.; Choi, Richard; Kushner, Arthur M.; Leiter, Lawrence A.; Al-Omran, Mohammed; Verma, Subodh; Mazer, C. David

The coronavirus disease 2019 (COVID-19) pandemic remains a source of considerable morbidity and mortality throughout the world. Therapeutic options to reduce symptoms, inflammatory response, or disease progression are limited. This randomized open-label trial enrolled 100 ambulatory patients with symptomatic COVID-19 in Toronto, Canada. Results indicate that icosapent ethyl (8g daily for 3 days followed by 4g daily for 11 days) significantly reduced high-sensitivity C-reactive protein (hs-CRP) and improved symptomatology compared with patients assigned to usual care. Specifically, the primary biomarker endpoint, change in hs-CRP, was significantly reduced by 25% among treated patients (-0.5mg/L, IQR[-6.9,0.4], within-group P=0.011). Conversely, a non-significant 5.6% reduction was observed among usual care patients (-0.1mg/L, IQR[-3.2,1.7], within-group P=0.51). An unadjusted between-group primary biomarker analysis was non-significant (P=0.082). Overall, this report provides evidence of an early anti-inflammatory effect of icosapent ethyl in a modest sample, including an initial well-tolerated loading dose, in symptomatic COVID-19 outpatients. ClinicalTrials.gov Identifier: NCT04412018.