A new Canadian study presented as a late-breaking clinical trial on December 12 at the National Lipid Association Conference found that the prescription drug Vascepa (icosapent ethyl) shows some promise for treating the symptoms of mild to moderate COVID-19. Those treated with the drug had a 25 percent reduction in the inflammatory biomarker high sensitivity C-reactive protein (CPR), and COVID-19 symptoms were significantly reduced compared with patients who were untreated. “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 Deepak L. Bhatt, MD, MPH, the executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center in Boston, a professor of medicine at Harvard Medical School, and a co-author of the study, during his presentation. “This is a very interesting study with promising results,” says Jim Liu, MD, a cardiologist at the Ohio State University Wexner Medical Center in Columbus. Vascepa (icosapent ethyl) is a formulation of EPA, which is a kind of omega-3 fatty acid that has been known to reduce inflammation, according to Dr. Liu. “Using it in this way for COVID-19 is very creative and novel. The results indicate that icosapent ethyl can lower inflammation and, more importantly, improve flu-like symptoms after 14 days,” he says.
What Is Vascepa and How Is It Typically Prescribed?
Vascepa was first approved by the U.S. Food and Drug Administration (FDA) in 2012 for adults with severely high triglyceride levels. It was given an additional approval in 2019 as an add-on therapy to reduce the risk of cardiovascular events such as heart attack and stroke in people whose triglyceride levels are 150 milligrams per deciliter or higher. The drug’s active ingredient is the omega-3 fatty acid eicosapentaenoic acid, derived from fish oil. The most common side effects reported in the clinical trials for Vascepa were musculoskeletal pain, peripheral edema (swelling of legs and hands), atrial fibrillation, and arthralgia (joint pain). In clinical trials, Vascepa significantly reduced the risk of heart attack or stroke. Taking the drug was associated with an increased risk of atrial fibrillation or flutter and an increased risk of bleeding events. Patients with allergies to fish or shellfish should be advised about the potential for allergic reactions. They should discontinue treatment and seek medical attention if any allergic reaction occurs, according to the FDA.
Vascepa Was Associated With Improvements in Muscle Aches and Respiratory Symptoms of COVID-19
The study was an open-label study, which means that the doctors and the people taking Vascepa were aware they were on the therapy. A total of 100 people who had tested positive for COVID-19 in the preceding three days were randomized to be given Vascepa or usual care (no treatment). “We studied COVID-19-positive outpatients who were symptomatic but ambulatory — that is, they felt bad, but not bad enough to be hospitalized,” says Dr. Bhatt. People in the Vascepa group were given a dose of 8 grams daily for 3 days, and then 4 grams daily for 11 days, for a total treatment time of two weeks. At the end of the trial, in addition to the reduction in inflammation, the prevalence of the measured symptoms was reduced from 100 percent at baseline to 48 percent, which indicates a 52 percent reduction; the group who didn’t receive any treatment had a 24 percent reduction in symptoms. Researchers assessed the symptoms of both groups with a tool known as FLU-PRO. The FLU-PRO assessment is a validated patient-reported questionnaire that measures the presence, severity, and duration of influenza-like symptoms, including those commonly reported with COVID-19. The greatest benefit was found in total symptoms, body or systemic symptoms such as muscle aches, and respiratory symptoms.
Next Steps
Since Vascepa is approved in the United States for patients with cardiovascular disease or diabetes only if they have elevated triglycerides, the use of this drug for COVID-19 would be considered “off-label” at this time, though physicians may choose to prescribe it if they feel it might be helpful, according to Bhatt. “We are doing studies using Vascepa in a much larger number of patients either with COVID-19 or at high risk for it. Those studies should be completed in the next few months and provide more definitive data,” he says. Bhatt and colleagues are also doing a study with 2,000 people who are at high risk of getting COVID-19 (such as essential healthcare workers) to see if the drug may have any role in preventing infection or lessening severity. To know the true effect of Vascepa on COVID-19, the study results need confirmation in a larger, blinded trial, according to Julio A. Chirinos, MD, PhD, an associate professor of cardiovascular medicine in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “This is particularly true for the patient-reported outcomes, in this case symptoms, which is highly subjective by nature, and therefore much less reliable in an open-label trial. In other words, participants knew whether they were receiving the study medication, which could have biased their symptom perception,” says Dr. Chirinos. “Ultimately, a larger double-blinded trial that is sufficiently powered to assess harder endpoints, such as the need for hospitalization, ICU care and/or death, as well as safety endpoints would be required to optimally assess the usefulness of this approach,” says Chirinos. The execution of randomized trials of novel approaches in COVID-19, as difficult as it is, remains the best approach to improve patient outcomes, according to Chirinos. “The investigators are to be congratulated for investigating this pharmacologic approach in a prompt and systematic manner,” he adds.
