A new randomized study could reduce the morbidity and mortality associated with COVID-19 and streamline clinical research at Yale. The study will enroll 466 patients across five different Yale New Haven Hospital sites to identify a potential COVID-19 treatment.
Led by Alexandra Lansky, MD, a professor of medicine and director of the Yale Cardiovascular Research Group (YCRG), the COLSTAT clinical trial (Colchicine/Statin for the Prevention of COVID-19 Complications) will combine two widely available medications to reduce complications in infected patients. Both have been in use for decades and have no adverse effects in patients with COVID-19.
Seeking the best available treatment
By March of 2020, the COVID-19 pandemic had sent shockwaves throughout the global community, spurring an urgent need for potential therapies to help patients. Lansky developed the idea along with her post doctoral research fellow Tayyab Shah, MD, now a resident at Yale New Haven Hospital, to combine colchicine with the cholesterol-lowering medication rosuvastatin based on an early report published June 24 from the University of Athens describing the clinical benefit of colchicine, an anti-inflammatory drug used to treat gout.
When the SARS-CoV-2 virus invades healthy cells, it triggers an inflammatory response to fight the virus. In severe cases, the patient’s immune system malfunctions. The resulting cytokine storm is a direct cause of complications including severe lung damage in COVID-19 patients. Lansky and colleagues hypothesized that if the body’s inflammatory response to COVID-19 could be blunted with commonly used medications, it could drastically improve outcomes in hospitalized patients.
Colchicine inhibits the protein-coding genes on a molecular level, which has the potential to reduce the SARS-CoV-2-induced inflammatory response. Statins also have direct anti-inflammatory effects by reducing chemokine—or signaling proteins—and adhesion molecules, and preventing the hyper-activation of T cells. When combined with standard care, colchicine and rosuvastatin may reduce the complications associated with acute respiratory distress syndrome (ARDS) and myocardial injury or heart attack.
The COLSTAT study is also noteworthy for being the first randomized clinical trial at Yale New Haven Hospital build within the EPIC electronic medical record, which enabled the trial to be deployed systemwide under one Institutional Review Board. Patient screening, recruitment, randomization, and follow up occur entirely in Yale’s electronic health record Epic.
By taking advantage of these systems, Lansky and her team were able to recruit patients in record time. She hopes this framework will have a lasting effect on how other clinical trials are conducted at Yale. “Everyone has come together and stepped up to the task of setting new standards, with enthusiasm and excitement to be part of a common mission to help win the battle against COVID-19,” Lansky said.
Yale is one of the world's leading institutions for biomedical research and advanced clinical care. To learn more about clinical research at Yale, please visit medicine.yale.edu/ycci. For more information about the study, please contact Marianne McCarthy.