AstraZeneca and Saint Luke’s Mid America Heart Institute have started a Phase 3 randomised clinical trial of Farxiga (dapagliflozin) to treat hospitalised COVID-19 patients who are at risk of developing serious complications, including organ failure.

The clinical trial, dubbed DARE-19, is aimed at evaluating the ability of Farxiga to reduce the risk of disease progression, clinical complications, and death of patients COVID-19, who also have cardiovascular (CV), metabolic or kidney risk factors.

AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos said: “AstraZeneca is committed to finding new solutions to fight COVID-19 by investigating the application of our new and existing medicines.

“With the Phase III DARE-19 trial, we aim to test whether Farxiga can prevent serious complications such as organ failure in those patients with pre-existing health conditions, a critical goal when treating COVID-19.”

The DARE-19 clinical trial will recruit approximately 900 COVID-19 patients

DARE-19 is an international, parallel-group, randomised, double-blind, placebo-controlled, investigator-sponsored Phase 3 trial evaluating the efficacy and safety of Farxiga.

Farxiga is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor used 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, weight loss and blood pressure reduction.

The DARE-19 trial is expected to recruit approximately 900 COVID-19 patients, with a medical history of hypertension (HTN), atherosclerotic CV disease, heart failure with reduced or preserved ejection fraction, T2D or CKD Stage III to IV, in the US and European countries.

Data on the protective effect of Farxiga in patients with heart failure with reduced ejection fraction (HFrEF), chronic kidney disease (CKD) or type 2 diabetes (T2D) would also support the trial.

The primary efficacy outcome of the trial includes time to the first occurrence of death from any cause or new or worsened organ dysfunction through 30 days of follow-up.

DARE-19 trial principal investigator Mikhail N Kosiborod 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 is common in patients with COVID-19.”