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

被引:20
作者
Kosmopoulos, Andrew [1 ,2 ,3 ]
Bhatt, Deepak L. [4 ]
Meglis, Gus [1 ]
Verma, Raj [1 ]
Pan, Yi [2 ]
Quan, Adrian [2 ]
Teoh, Hwee [2 ,5 ]
Verma, Maya [1 ]
Jiao, Lixia [6 ]
Wang, Robert [6 ]
Juliano, Rebecca A. [6 ]
Kajil, Mahesh [1 ]
Kosiborod, Mikhail N. [7 ,8 ,9 ,10 ]
Bari, Basel [11 ]
Berih, Abdullahi A. [12 ]
Aguilar, Mallory [1 ]
Escano, Antonnette [1 ]
Leung, Andrew [13 ]
Coelho, Idelta [13 ]
Hibino, Makoto [2 ]
Diaz, Rafael [14 ]
Mason, R. Preston [15 ]
Steg, Ph Gabriel [16 ,17 ,18 ]
Simon, Tabassome [17 ,19 ]
Go, Alan S. [20 ,21 ,22 ]
Ambrosy, Andrew P. [20 ,23 ]
Choi, Richard [24 ,25 ]
Kushner, Arthur M. [26 ]
Leiter, Lawrence A. [5 ,27 ,28 ]
Al-Omran, Mohammed [29 ,30 ]
Verma, Subodh [1 ,2 ,3 ,30 ,31 ]
Mazer, C. David [32 ,33 ,34 ]
机构
[1] North York Diagnost & Cardiac Ctr, Toronto, ON, Canada
[2] St Michaels Hosp, Unity Hlth Toronto, Li Ka Shing Knowledge Inst, Div Cardiac Surg, Toronto, ON, Canada
[3] Univ Toronto, Dept Pharmacol & Toxicol, Toronto, ON, Canada
[4] Brigham & Womens Hosp, Harvard Med Sch, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA
[5] St Michaels Hosp, Unity Hlth Toronto, Li Ka Shing Knowledge Inst, Div Endocrinol & Metab, Toronto, ON, Canada
[6] Amarin Pharma Inc, Bridgewater, NJ USA
[7] St Lukes Mid Amer Heart Inst, Dept Cardiol, Kansas City, MO USA
[8] Univ Missouri Kansas City, Dept Med, Kansas City, MO USA
[9] George Inst Global Hlth, Sydney, NSW, Australia
[10] Univ New South Wales, Sydney, NSW, Australia
[11] Markham Hlth Plex Med Ctr, Markham, ON, Canada
[12] Humber Ctr Family Hlth, Etobicoke, ON, Canada
[13] Alpha Labs Inc, Toronto, ON, Canada
[14] Inst Cardiovasc Rosario, Estudios Clin Latino Amer, Rosario, Argentina
[15] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA 02115 USA
[16] Univ Paris, AP HP, INSERM 1148, Paris, France
[17] French Alliance Cardiovasc Trials FACT, Paris, France
[18] Imperial Coll, Royal Brompton Hosp, Natl Heart & Lung Inst NHLI, London, England
[19] Sorbonne Univ, Hop St Antoine, AP HP,Site St Antoine, Dept Clin Pharmacol,Unite Rech Clin URCEST,INSERM, Paris, France
[20] Kaiser Permanente Northern Calif, Div Res, Oakland, CA USA
[21] Univ Calif San Francisco, Dept Epidemiol Biostat & Med, San Francisco, CA 94143 USA
[22] Stanford Univ, Dept Med, Sch Med, Div Nephrol, Stanford, CA 94305 USA
[23] Kaiser Permanente San Francisco Med Ctr, Div Cardiol, San Francisco, CA USA
[24] St Josephs Hlth Ctr, Unity Hlth Toronto, Riverside Cardiol & Diagnost Imaging, Toronto, ON, Canada
[25] St Josephs Hlth Ctr, Unity Hlth Toronto, Div Cardiol, Toronto, ON, Canada
[26] Humber River Hosp, Toronto, ON, Canada
[27] Univ Toronto, Dept Med, Toronto, ON, Canada
[28] Univ Toronto, Dept Nutr Sci, Toronto, ON, Canada
[29] St Michaels Hosp, Unity Hlth Toronto, Li Ka Shing Knowledge Inst, Div Vasc Surg, Toronto, ON, Canada
[30] Univ Toronto, Dept Surg, Toronto, ON, Canada
[31] Canadian Med & Surg Knowledge Translat Res Grp, Toronto, ON, Canada
[32] St Michaels Hosp, Unity Hlth Toronto, Li Ka Shing Knowledge Inst, Dept Anesthesia, Toronto, ON, Canada
[33] Univ Toronto, Dept Anesthesiol & Pain Med, Toronto, ON, Canada
[34] Univ Toronto, Dept Physiol, Toronto, ON, Canada
关键词
Health sciences; Medicine;
D O I
10.1016/j.isci.2021.103040
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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], withingroup 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.
引用
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页数:11
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