COVID-19 study paves way for virtual clinical trial
A study completed by UnitedHealth Group with the Yale School of Medicine found that older COVID-19 patients with hypertension taking angiotensin-converting enzyme (ACE) inhibitors had a lower risk of COVID-19 hospitalization. A pragmatic clinical trial will be a critical next step.
The study, which was recently submitted for peer-reviewed publication, analyzed retrospective data from about 10,000 patients testing positive for SARS-CoV-2 who were enrolled in Medicare Advantage or commercially insured plans, and had a prescription for one or more anti-hypertensive medications. The use of ACE inhibitors was associated with an almost 40% lower risk of COVID-19 hospitalization for Medicare Advantage patients. A younger, commercially insured group did not have the same result. Use of the medication was not found to reduce mortality risk in individuals once hospitalized with COVID-19.
“While not yet actionable, these findings provide an impetus to test whether this common, inexpensive class of drugs can mitigate the impact of the virus,” said Dr. Harlan Krumholz, the Harold H. Hines, Jr. professor of medicine at Yale and the director of the Yale New Haven Hospital Center for Outcomes Research.
The findings of this analysis clear a path for a pragmatic, large-scale clinical research trial to examine the potential role of ACE inhibitors in preventing the severe consequences of COVID-19. The large-scale research trial led by UnitedHealth Group and Yale School of Medicine will adopt an innovative, modern approach as one of the first virtual COVID-19 clinical trials to be launched at scale with a suite of digital tools.
“The results from this study offer critical new insights that can help accelerate clinical trials on ACEs to inform appropriate hypertension treatments for seniors during the COVID-19 pandemic,” said Dr. Deneen Vojta, executive vice president, Global Research & Development for UnitedHealth Group. “We are hopeful this information will help clinicians, health care researchers and industry leaders work together to validate these findings and possibly reduce the risk of hospitalization for COVID-19.”