iScience (Sep 2021)
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 N. Kosiborod,
- Basel Bari,
- Abdullahi A. Berih,
- Mallory Aguilar,
- Antonnette Escano,
- Andrew Leung,
- Idelta Coelho,
- Makoto Hibino,
- Rafael Díaz,
- R. Preston Mason,
- Ph. Gabriel 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
Affiliations
- Andrew Kosmopoulos
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada; Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Department of Pharmacology & Toxicology, University of Toronto, Toronto, ON, Canada
- Deepak L. Bhatt
- Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis St., Boston, MA 02115, USA; Corresponding author
- Gus Meglis
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Raj Verma
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Yi Pan
- Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada
- Adrian Quan
- Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada
- Hwee Teoh
- Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Division of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada
- Maya Verma
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Lixia Jiao
- Amarin Pharma Inc., Bridgewater, NJ, USA
- Robert Wang
- Amarin Pharma Inc., Bridgewater, NJ, USA
- Rebecca A. Juliano
- Amarin Pharma Inc., Bridgewater, NJ, USA
- Mahesh Kajil
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Mikhail N. Kosiborod
- Department of Cardiology, Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA; Department of Medicine, University of Missouri-Kansas City, Missouri, USA; The George Institute for Global Health, Sydney, NSW, Australia; University of New South Wales, Sydney, NSW, Australia
- Basel Bari
- Markham Health+Plex Medical Centre, Markham, ON, Canada
- Abdullahi A. Berih
- Humber Centre for Family Health, Etobicoke, ON, Canada
- Mallory Aguilar
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Antonnette Escano
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada
- Andrew Leung
- Alpha Laboratories Inc., Toronto, ON, Canada
- Idelta Coelho
- Alpha Laboratories Inc., Toronto, ON, Canada
- Makoto Hibino
- Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada
- Rafael Díaz
- Estudios Clínicos Latino América, Instituto Cardiovascular de Rosario, Rosario, Argentina
- R. Preston Mason
- Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
- Ph. Gabriel Steg
- Université de Paris, Assistance Publique-Hôpitaux de Paris, INSERM 1148, Paris, France; French Alliance for Cardiovascular Trials (FACT), Paris, France; National Heart & Lung Institute NHLI, Imperial College, Royal Brompton Hospital, London, UK
- Tabassome Simon
- French Alliance for Cardiovascular Trials (FACT), Paris, France; Department of Clinical Pharmacology, Unité de Recherche Clinique (URCEST), Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, Sorbonne Université, site St Antoine, INSERM U-698, Paris, France
- Alan S. Go
- Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Departments of Epidemiology, Biostatistics and Medicine, University of California at San Francisco, San Francisco, CA, USA; Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA
- Andrew P. Ambrosy
- Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Division of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA
- Richard Choi
- Riverside Cardiology and Diagnostic Imaging; Division of Cardiology, St. Joseph's Health Centre, Unity Health Toronto, Toronto, ON, Canada
- Arthur M. Kushner
- Humber River Hospital, Toronto, ON, Canada
- Lawrence A. Leiter
- Division of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Nutritional Sciences, University of Toronto, Toronto, ON, Canada
- Mohammed Al-Omran
- Division of Vascular Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Department of Surgery, University of Toronto, Toronto, ON, Canada
- Subodh Verma
- North York Diagnostic and Cardiac Centre, Toronto, ON, Canada; Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Department of Pharmacology & Toxicology, University of Toronto, Toronto, ON, Canada; Department of Surgery, University of Toronto, Toronto, ON, Canada; Canadian Medical and Surgical Knowledge Translation Research Group, Toronto, ON, Canada
- C. David Mazer
- Department of Anesthesia, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Department of Physiology, University of Toronto, Toronto, ON, Canada
- Journal volume & issue
-
Vol. 24,
no. 9
p. 103040
Abstract
Summary: 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.
