Trial started with SGLT2i in COVID-19News - May 4, 2020
A randomized global phase 3 trial has been initiated to evaluate whether the SGLT2 inhibitor dapagliflozin can reduce disease progression, clinical complications and death in patients hospitalized with COVID-19 and who also have CV, metabolic or kidney risk factors.
In COVID-19 patients, cardiac, renal and metabolic comorbidities have been associated with poor outcomes and increased mortality risk. Mikhail Kosiborod, MD, cardiologist at Saint Luke’s Mid America Heart Institute and principal investigator of DARE-19 said: “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 an international, parallel-group, randomized, double-blind, placebo-controlled, investigator-sponsored phase III trial examining the efficacy and safety of dapagliflozin in addition to standard of care therapy. The effect of dapagliflozin on risk of all-cause death or disease progression and complications is studied in adults who are hospitalized with COVID-19 at the time of enrollment. In addition, eligible patients have a medical history of hypertension, atherosclerotic CVD, heart failure with reduced or preserved ejection fraction, T2DM or CKD stage III to IV. Primary outcome is time to first occurrence of death from any cause or new/worsened organ dysfunction after 30 days of follow-up.
The DARE-19 trial is open for enrollment in the US and Europe, and aims to recruit ~900 patients.