Scientists at the Kaiser Permanente Northern California Division of Research started a clinical trial in August, called MITIGATE COVID-19, that will look at whether a drug used to reduce the risk of heart disease and stroke can also prevent or reduce the risk of COVID-19, the flu, or similar viral illnesses.
Researchers are inviting 1,500 Kaiser Permanente Northern California members to participate in the trial. Participants must be 50 years or older, have access to email, and have atherosclerotic cardiovascular disease. This type of heart disease is caused by the buildup of fat, cholesterol, and other substances known as plaque in the walls of the blood vessel.
“People who have atherosclerotic cardiovascular disease are at higher risk of getting COVID-19 and they are at greater risk of having complications,” explained Jack Skarbinski, MD, an infectious disease specialist in The Permanente Medical Group and adjunct investigator at the Division of Research.
A control group of 15,000 who have the same type of heart disease will not be given the drug. But they will be under the regular care of their Kaiser Permanente physicians. Researchers will monitor the health of everyone in the study throughout the fall and spring to see whether the drug helps prevent or reduce the severity of COVID-19 or other respiratory viruses. The results will be known in about a year.
“This trial is only possible because Kaiser Permanente is an integrated health care delivery system with comprehensive electronic health records and rigorous clinical trial infrastructure,” said study co-leader Alan S. Go, MD, a research scientist at the Division of Research and regional medical director of the Clinical Trials Program based at the Division of Research.
The trial’s design will also make it easier “to quickly put the drug into clinical care if it does prove to be beneficial,” added Dr. Go. “It’s also one of the first COVID-19 prevention trials that doesn’t involve a vaccine or isn’t only enrolling health care workers.”
Icosapent ethyl (Vascepa) is approved by the U.S. Food and Drug Administration to reduce the risk of heart attacks or strokes in people with heart disease or diabetes. The study is funded by Amarin Corporation, which makes Vascepa.
Most randomized trials have many restrictions about who can take part, said study co-leader Andrew P. Ambrosy, MD, a research scientist at the Division of Research and a cardiologist in The Permanente Medical Group.
“We streamlined eligibility criteria and are focusing on high-risk patients for whom this drug is already approved,” Ambrosy said.
The group of 1,500 who join the trial will have the drug mailed to their home, and the study team will check in with trial participants monthly to see if they are taking their medication and whether they have any problems or concerns.
This story originally appeared in Look Inside KP