A randomized trial of icosapent ethyl in ambulatory patients with COVID-19
Andrew Kosmopoulos, Deepak L. Bhatt, Gus Meglis, Raj Verma, Yi Pan, Adrian Quan, Hwee Teoh, Maya Verma, Lixia Jiao, Robert Wang, Rebecca A. Juliano, Mahesh Kajil, Mikhail Kosiborod, Basel Bari, Abdullahi A. Berih, Mallory Aguilar, Antonnette Escano, Andrew Leung, Idelta Coelho, Makoto Hibino, Rafael Tejeda Díaz, R. Preston Mason, Philippe Gabríel Steg, Tabassome Simon, Alan S. Go, Andrew P. Ambrosy, Richard Choi, Arthur M. Kushner, Lawrence A. Leiter, Mohammed Al‐Omran, Subodh Verma, C. David Mazer
Abstract
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 (8 g daily for 3 days followed by 4 g 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 (-0.5 mg/L, interquartile range [IQR] [-6.9,0.4], within-group p = 0.011). Conversely, a non-significant 5.6% reduction was observed among usual care patients (-0.1 mg/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 outpatients with COVID-19. ClinicalTrials.gov Identifier: NCT04412018.