DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced support for an investigator-initiated trial to study the effects of icosapent ethyl (VASCEPA®) (IPE) on laboratory-confirmed viral upper respiratory infection (URI) rates, clinical impact and outcomes, especially with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection which causes COVID-19, in adults with established atherosclerotic cardiovascular disease (ASCVD) who are at elevated risk of experiencing moderate to severe COVID-19.1,2
The trial, dubbed PragMatic randomIzed Trial of Icosapent ethyl for hiGh-cArdiovascular risk adults in The Era of COronaVIrus Disease 2019 (MITIGATE COVID-19), is sponsored by Kaiser Permanente Northern California (KPNC), and is being led by Dr. Andrew P. Ambrosy, Associate Program Director for Research (Fellowship), Department of Cardiology, Kaiser Permanente San Francisco Medical Center, and Dr. Alan S. Go, Regional Medical Director, Clinical Trials Program and Associate Director, Cardiovascular and Metabolic Conditions Research, Division of Research, Kaiser Permanente Northern California.
MITIGATE COVID-19 will randomly assign 1500 U.S. patients aged 50 years or older with established ASCVD and no prior history of confirmed COVID-19 to receive 4 grams per day of icosapent ethyl (VASCEPA) and follow these patients for a minimum of 6 months. The co-primary study endpoints are the rate of moderate to severe laboratory-confirmed viral URI, including COVID-19 and influenza, prompting urgent care encounters, emergency department visits, or hospitalization and the worst clinical status due to a laboratory-confirmed viral URI based on an ordinal scale taking hospitalization, death, supplemental oxygen, and other clinical factors into account. A control group will consist of 15,000 adults meeting the same eligibility criteria who will be passively followed through KPNC’s comprehensive and state-of-the-art electronic health record system for outcome ascertainment.
Current understanding of the biology of COVID-19 is that patients that have or are at high risk for developing ASCVD are at higher risk of death and severe effects from infection, and that the morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the body’s robust inflammatory response leading to ‘cytokine storm’.1,2,3,4 Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6
The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:
- Potential antiviral/antimicrobial effects7,8
- Fibrosis and cardiac damage mitigation in animal models9,10
- Anti-inflammatory effects (acute) in pulmonary/lung tissue11,12
“Most prior clinical trials for COVID-19 have focused on treating patients hospitalized for moderate or severe COVID-19 with experimental agents,” according to Dr. Ambrosy. “MITIGATE COVID-19 is novel in that we will study the effects of pre-treatment with IPE, an FDA-approved therapy for primary and secondary prevention with putative anti-inflammatory as well as antiviral properties, in high-risk outpatients with ASCVD on subsequent risk of viral URI-related morbidity and mortality.”
Dr. Go further stated, “In my 20+ years as a health services researcher and clinical trialist, this is the first time that a large-scale study will be undertaken using a completely virtual model including patient recruitment and consent, follow-up visits, and outcome ascertainment within an ethnically-diverse, community-based population. Kaiser Permanente Northern California has been at the forefront of telehealth for delivering high-quality clinical care, especially during the current pandemic, and we are pleased to be able to adapt this innovative approach for safely and efficiently testing a potential intervention.”
For more information about Amarin’s COVID-19 research, please visit the COVID-19 Related Materials section on Amarin’s publications page at https://investor.amarincorp.com/publications.