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Friday, August 7, 2020

Kaiser to launch study of Amarin’s Vascepa in COVID-19

Investigators at Kaiser Permanente plan to launch a study evaluating the effects of Amarin’s (AMRN +0.4%) Vascepa (icosapent ethyl) on upper respiratory infection (URI) rates and clinical outcomes, especially involving acute viral respiratory infection from SARS-CoV-2, in adults with established atherosclerotic cardiovascular disease (ASCVD) at elevated risk of experiencing moderate-to-severe COVID-19.
The trial, MITIGATE COVID-19, will recruit 1,500 subjects at least 50 years old with established ASCVD and no prior history of COVID-19 infection to receive 4 gm of Vascepa each day for at least six months.
The co-primary endpoints will be 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 Kaiser’s electronic health record system for outcome ascertainment.
“Amarin does not have multiple ‘shots on goal’, has divergent analyst opinions on it, has a critical legal battle going on and is a volatile stock,” Seeking Alpha’s Bret Jensen wrote at the end of July “This disqualifies it from being a large or core holding. However, the name sets up quite well for a covered call candidate.”

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