A phase 3 trial to evaluate dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a potential treatment for patients hospitalized with coronavirus disease 2019 (COVID-19) who are at risk of developing serious complications, has been initiated by AstraZeneca and Saint Luke’s Mid America Heart Institute.
The multicenter, randomized, double-blind, placebo-controlled DARE-19 trial will assess the efficacy and safety of dapagliflozin in reducing disease progression, clinical complications and death due to COVID-19 in hospitalized adult patients with underlying comorbidities.
Approximately 900 patients with a medical history of hypertension, atherosclerotic cardiovascular disease, heart failure with reduced or preserved ejection fraction, type 2 diabetes or chronic kidney disease Stage 3 or 4 will be enrolled. Patients will receive either dapagliflozin 10mg or placebo once daily for 30 days. The primary efficacy end point will be the time to first occurrence of death from any cause or new/worsened organ dysfunction through 30 days of follow-up.
“Dapagliflozin has demonstrated cardio and renal protective benefits and improved outcomes in high-risk patients with type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease,” said Mikhail N. Kosiborod, MD, cardiologist at Saint Luke’s Mid America Heart Institute, Vice President of Research at Saint Luke’s Health System, and principal investigator of DARE-19. “Through DARE-19, we hope to decrease the severity of illness, and prevent cardiovascular, respiratory and kidney decompensation, which are common in patients with COVID-19.”
A recent report published by the Centers for Disease Control and Prevention (CDC) revealed that the majority of patients hospitalized with COVID-19 were found to have an underlying condition such as chronic lung disease, hypertension, cardiovascular disease, and diabetes.
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is marketed under the brand name Farxiga and is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also approved to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
For more information astrazeneca.com.