So researchers conducted a randomized controlled clinical trial that studied hospitalized patients who were critically ill with COVID-19, focusing on how statins may impact two COVID-19 complications: blood clots and acute respiratory distress syndrome (ARDS). The trial included nearly 600 people in Iran who had been admitted into intensive care units (ICUs) in 11 hospitals because of COVID-19. Half the patients were given 20 milligrams (mg) daily of a statin called atorvastatin while the other half were given a placebo. At the end of 30 days, researchers recorded instances of blood clots, use of extracorporeal membrane oxygenation — prolonged lung and cardiovascular life support that is commonly used to treat ARDS — or all-cause death within 30 days of the trial’s start. The study did not show the results researchers expected to see. When patients started taking the drug after being admitted to the hospital, the recommended starting dose of a statin — 20 mg — did not make a difference in patients’ outcomes. It didn’t make patients worse or increase the incidence of side effects such as bleeding, but it didn’t mitigate blood clots or other complications, either. “Statin therapy under the intensity that we used is not suitable to treat people with COVID-19, but the door is still open for lipid-modifying therapies,” says Behnood Bikdeli, MD, a cardiologist at Brigham and Women’s Hospital in Boston, who led the trial. He and his colleagues presented the study’s findings virtually on May 16, 2021, at the American College of Cardiology’s (ACC) 70th Annual Scientific Session and Expo. Dr. Bikdeli and his team hoped that statins, which have a therapeutic anti-inflammatory effect, might be useful in treating conditions like ARDS, which is caused by an intense inflammatory response and is a common side effect in critically ill COVID-19 patients. The new data did suggest that statin therapy may help patients who become severely ill and are hospitalized and given a statin within seven days of their first symptoms of COVID-19. But Bikdeli says additional data is needed to determine whether this was a fluke. “Our hope was that it would help, and now we can talk about a couple of potential reasons why it didn’t,” says Bikdeli, noting that dosage may be a potential factor, but that a higher dose may cause liver injury, which COVID-19 patients are already at higher risk of. “But it did show that statins are very safe in people with COVID-19.”
The Race for Data
According to Michael Tran, DO, a vascular medical internist at Cleveland Clinic who was not involved with either study, the race to understand how SARS-CoV-2 acts in the body has led to a lot of guesswork. “When the pandemic first started, we relied heavily on what we already knew about ARDS therapies. There were existing protocols for how we would regulate oxygen in those patients, but some of these therapies that have traditionally been effective didn’t work in this case,” says Dr. Tran. “That’s why a lot of these therapies that we were optimistic about early on, such as hydroxychloroquine, ultimately proved to not be very helpful." Tran wasn’t surprised that statins didn’t change a person’s risk of blood clots or ARDS. “Inflammation in itself is a really complex topic, because there are so many different pathways of inflammation, and different medications affect different pathways, and they might not cross over. I may use a statin medication for a plaque disease, which does have something to do with inflammation, but not for thrombosis, because those inflammation pathways can really be different in how they come about,” says Tran. Moving forward, Tran expects researchers to continue to hone their understanding of COVID-19 by retrospectively looking at databases that hospitals have been building since the pandemic began. This data can reveal shared factors in COVID-19 patients who experienced blood clots, ARDS, and other complications. Researchers can then explore whether there is a common mechanism that can be treated, which could improve outcomes. “COVID-19 isn’t going away. We don’t yet know how it will change over time, but this is a disease, just like the flu, that will be ever-present. And it’s important to continue to understand what parts of the immune system the disease affects and what seems to increase a person’s risk for ARDS and thrombosis. This allows us to have more dialed-in protocols that decrease the number of people dying of COVID-19,” says Tran.
