Candidate: Vascepa® (icosapent ethyl)
Type: Ethyl ester of eicosapentaenoic acid (EPA) initially indicated as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa was approved for reduction of cardiovascular risk in December 2019.
Status: Amarin said August 7 it will support an investigator-initiated trial designed to study Vascepa on laboratory-confirmed viral upper respiratory infection (URI) rates, clinical impact and outcomes, especially with SARS-CoV-2, in adults with established atherosclerotic cardiovascular disease (ASCVD) who are at elevated risk of experiencing moderate to severe COVID-19. Amarin reasons that Vascepa may help prevent SARS-CoV-2 infection, and potentially reduce clinical severity in patients infected by the virus.
The trial—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).
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 Vascepa, and follow these patients for a minimum of six 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.
A control group will consist of 15,000 adults meeting the same eligibility criteria who will be passively followed through KPNC’s electronic health record system.
Lead investigators for the trial are Andrew P. Ambrosy, MD, associate program director for research (Fellowship), department of cardiology, Kaiser Permanente San Francisco Medical Center; and Alan S. Go, MD, regional medical director, Clinical Trials Program and associate director, cardiovascular and metabolic conditions research, division of research, KPNC.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
