Back

A randomized trial of icosapent ethyl in ambulatory patients with COVID-19.

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.

Authors

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
Published Date 2021 Sep 24