Canadian pilot study suggests prescription icosapent ethyl (VASCEPA®) might improve symptoms of COVID-19 and reduce inflammation

TORONTO,ON,Dec. 14,2020 -- The results of a Canadian study released this weekend provides encouraging data suggestingthat the prescription strength omega-3 called icosapent ethyl (VASCEPA) may reduce inflammation and improve symptoms in patients with a diagnosis of COVID-19.

"This study provides the first evidence of an early anti-inflammatory effect of icosapent ethyl in symptomatic COVID-19 positive outpatients – who represent the majority of patients affected by this disease in the community",said Professor Deepak L. Bhatt,Brigham and Women's Hospital and Harvard Medical School.

The study was conducted by The Canadian Medical and Surgical Knowledge Translation Research Group through an investigator-initiated grant from HLS Therapeutics and Amarin Pharmaceuticals. The study was presented by Professor Bhatt as a Late-Breaking Clinical Trial on December 12th at the National Lipid Association Conference.

"The large and significant improvement in patient-reported symptoms may provide a safe,well-tolerated,and relatively inexpensive option to impact upon COVID-19 related morbidity,though this finding should be confirmed in a double-blind,placebo-controlled trial,"said Dr. Bhatt,during his presentation.

About the Study

The Health Canada approved study was conducted by The Canadian Medical & Surgical Knowledge Translation Research Group.

100 Canadian COVID-19 positive patients in the community were recruited through their family physicians. They had all been diagnosed as COVID-19 positive in the preceding 3 days. Patients were randomized to receive either VASCEPA or usual care (no treatment) in an open label study. VASCEPA,a highly purified omega-3 fatty acid available by prescription,was given at a dose of 8 grams daily for 3 days and then 4 grams daily for 11 days (total treatment 2 weeks).

Treatment with VASCEPA led to a 25% reduction in the inflammatory biomarker,high sensitivity C-Reactive protein (CRP),which was statistically significant. Treatment with VASCEPA also improved overall symptoms. At the end of the 14-day treatment period,the prevalence of FLU-PRO symptoms was significantly reduced from 100% (at baseline) to 48% - indicating a 52% reduction in symptoms compared to 24% in the untreated patients. The FLU-PRO score is a validated patient-reported outcome measure to evaluate the presence,severity and duration of flu symptoms. Treatment was well tolerated with no major side effects.

There were other,potentially significant benefits of VASCEPA noted with respect to the domains of body/systemic symptoms and chest/respiratory symptoms as assessed by FLU-PRO scores.

"For the vast majority of patients in my practice that are diagnosed with COVID-19 who have mild to moderate symptoms,this could providea safe and potentially effective approach to consider" said Dr. Gus Meglis,a family physician and member of the steering committee who was involved in the study. Dr. Arthur Kushner,a family physician and steering committee member found the results to be "important" and that they could offer an option for the many patients in the community.

"These exciting results should be studied in a larger number of patients in a double-blind randomized fashion – and studies of this nature such as PREPARE-IT 1 and PREPARE-IT 2 are currently ongoing with VASCEPA," said Dr. Subodh Verma,a co-investigator of the study.

About the Canadian Medical and Surgical Knowledge Translation Research Group

The Canadian Medical & Surgical Knowledge Translation Research Group is a federally incorporated not-for-profit academic physician research organization. Vascepa is not indicated for the treatment of COVID-19.

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