DARE-19 Phase III Collaboration between AstraZeneca, Saint Luke’s Mid America Heart Institute and George Clinical Shows Treatment’s Well-Established Safety Profile Was Consistent in Patients with COVID-19
OVERLAND PARK, KS, July 29, 2021 (GLOBE NEWSWIRE) — The findings of DARE-19, a double-blind, placebo-controlled Phase III trial examining Dapagliflozin in patients with cardiometabolic risk factors hospitalized with COVID-19, have been published in The Lancet Diabetes & Endocrinology. The study was a collaboration of George Clinical, a global scientifically-backed clinical research organization and Saint Luke’s Mid America Heart Institute and was funded by AstraZeneca.
Prior to the study, it was established that patients hospitalized with COVID-19 with cardiometabolic risk factors had an elevated risk of organ failure and death. DARE-19 was the first large, randomized controlled study of hosptialized patients with COVID-19 to evaluate the safety and efficacy of SGLT2 inhibitors. Detailed results from the primary analysis of the DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to treat patients hospitalized with COVID-19 who are at risk of developing serious complications, showed that the trial did not achieve statistical significance for the two primary endpoints. However, there were numerically fewer events of death or new or worsened organ dysfunction in the Farxiga group compared with placebo.
The primary endpoint of prevention was defined as new or worsened respiratory, cardiovascular or kidney organ dysfunction during hospitalization or death from any cause during the 30-day treatment period. Numerically fewer events were observed in the Farxiga group across all components of this composite endpoint. Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalized with COVID-19 The second primary endpoint of recovery, which assessed change in clinical status (improvement or deterioration) compared to baseline, showed no overall difference between the treatment groups.
“The ability to rapidly start and execute this study during the midst of a major global pandemic is a credit to the entire cross-functional project team,” stated George Clinical Chief Business Officer, Sean Hart. “In a month we broke down barriers to go from concept to our first patient in the trial, and the team displayed extraordinary commitment needed to successfully manage this research during this pandemic personally and professionally.”
Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Vice President of Research at Saint Luke’s Health System, and a member of George Clinical’s Scientific Leadership was the principal investigator of DARE-19. The study was an international Phase III trial in 1,250 patients evaluating the efficacy and safety of Farxiga in addition to background local standard of care therapy in adults who are hospitalized with COVID-19 at the time of trial enrollment. Patients enrolled in DARE-19 also had a medical history of hypertension, type-2 diabetes (T2D), atherosclerotic cardiovascular disease, heart failure (HF) or chronic kidney disease (CKD) Stages 3-4 and received Farxiga or placebo for 30 days. The trial was conducted in collaboration with Saint Luke’s Mid America Heart Institute, the global sponsor, and George Clinical, a global contract research organization.
“DARE-19 is one of the few randomization controlled, double blind clinical trials for COVID-19 that has been completed during the pandemic. This accomplishment is due to the tireless work and commitment of our Investigators, site staff and the study team members across the sponsor, George Clinical, and our partners. Their dedication to the project during a time of significant personal stress is the key reason these results are available for the scientific community,” said Emily Akin, Project Director for George Clinical.
About George Clinical
George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With more than 20 years of experience and more than 300 people managing 38 geographical locations throughout the USA, Asia-Pacific region and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.
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