AstraZeneca and Saint Luke’s Mid America Heart Institute have initiated a randomized, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalized with COVID-19 who are at risk of developing serious complications, such as organ failure. Called DARE-19, the goal of this study is to investigate whether Farxiga, a sodium-glucose contransporter 2 (SGLT2) inhibitor, can reduce the the risk of disease progression, clinical complications, and death due to COVID-19 in patients who also have cardiovascular (CV), metabolic or kidney risk factors.
The DARE-19 trail is open for enrollment in the U.S. and other European countries with a high COVID-19 burden and aims to recruit approximately 900 patients.
DARE-19 is an international, parallel-group, randomized, double-blind, placebo-controlled, investigator-sponsored Phase III trial evaluating the efficacy and safety of Farxiga in addition to background local standard of care therapy, on the risk of all-cause death or disease progression and complications in adults who are hospitalized with COVID-19 at the time of trial enrolment. Patients enrolled in DARE-19 also have a medical history of hypertension (HTN), atherosclerotic CV disease, heart failure with reduced or preserved ejection fraction, T2D or CKD Stage III to IV. The primary efficacy outcome of the trial is time to first occurrence of death from any cause or new/worsened organ dysfunction through 30 days of follow-up.
The Health Challenge
Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in COVID-19 patients. The trial design is supported by extensive data on the protective effort of Farxiga in patients with heart failure with reduced ejection faction (HFeEF), chronic kidney disease (CKD) or type 2 diabetes (TD2).
The Research Site
Saint Luke’s Mid America Heart Institute includes 18 hospitals and campuses across the Kansas City region, home care and hospice, behavioral health care, dozens of physician practices, a life care senior living community. Executive Vice President Mikhail N.Kosiborod, MD, cardiologist and principal investigator of DARE-19, noted, “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, respirator and kidney decompensation, which are common in patients with COVID-19.”
Farxiga is a first-in-class, oral, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction. In the DECLARE CV outcomes trial in adults with T2D, Farxiga reduced the risk of the composite endpoint of hospitalization for HF or CV death versus placebo, when added to standard of care.
Executive Vice President Mikhail N.Kosiborod, MD cardiologist and principal investigator of DARE-19