AstraZeneca and Saint Luke’s Mid America Heart Institute in Kansas City, MO have initiated a randomized, global Phase III trial that uses Farxiga as a treatment in patients hospitalized with coronavirus who are at risk of developing serious complications, such as organ failure.
The goal of the trial, called DARE-19, is to assess whether Farxiga, a diabetes drug, reduces the risk of disease progression, clinical complications, and death due to COVID-19 in patients who also have cardiovascular, metabolic or kidney risk factors.
Many of the deaths arising from the virus have come from people with underlying health factors including. heart disease and diabetes.
The trial design is supported by data from numerous trials for the heavily advertised drug that as of July had generated more than $725 million in 2019 sales for AstraZeneca.
AstraZeneca employs 1,500 in administrative, headquarters and logistics operations in northern Delaware
Mikhail N. Kosiborod, M.D., 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 said: “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. Patients with COVID-19 and underlying cardiometabolic disease appear to be at the highest risk of morbid complications. 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.”
The DARE-19 trial is open for enrolment in the US and other European countries with a high COVID-19 burden and aims to recruit approximately 900 patients.