AstraZeneca and Saint Luke’s Mid America Heart Institute have kicked off a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.
The goal of the trial, called DARE-19, is to determine whether Farxiga, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, can hold back disease progression and reduce the risk of clinical complications, and death due to COVID-19 in patients who also have cardiovascular (CV), metabolic or kidney risk factors.
Cardiac, renal and metabolic comorbidities are linked with poor outcomes and death in COVID-19 patients. The trial design is supported by extensive data on the protective effect of Farxiga in patients with heart failure with reduced ejection fraction (HFrEF), chronic kidney disease (CKD) or type II diabetes.
“Dapagliflozin has demonstrated cardio and renal protective benefits and improved outcomes in high-risk patients with type II 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,” said Mikhail Kosiborod, 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.”
The trial is open for enrolment in the US and other European countries with a high COVID-19 burden and aims to recruit around 900 patients.
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