Dr. Mikhail Kosiborod with Saint Luke’s Mid-America Heart Institute is leading a clinical trial investing the use of a diabetic drug called dapagliflozin. Apparently, a new study commenced to look the drug as a means of protecting vital organs from damage caused by COVID-19.
With the study’s launch just last week, sponsor Saint Luke’s Health System along with collaborator (and drug maker) AstraZeneca set up this international, multicenter, parallel-group, randomized, double-blind, placebo controlled clinical trial for hospitalized adult patients with COVID-19 in the United States and other countries with high prevalence of COVID-19. The study team now evaluates the effect of 10mg of dapagliflozin versus placebo, given once daily for 30 days in addition to the local standard of care therapy with the goal of reducing disease progression, complication and all-cause mortality.
Seeking a total of 900 participants, the study will include sites around the world including places such as Australia as CRO George Clinical also participates to help manage the study. Some of the participants are already enrolled at the Kansas City sponsor. These patients are already hospitalized with COVID-19 but not critical enough to be in the intensive care unit (ICU).
The study’s primary endpoint takes into account the period from randomization through Day 30 with investigators focusing on time to first occurrence of either death from any cause or new/worsened organ dysfunction. Other factors under study include respiratory decompensation, new or worsening congestive HF, requirement for vasopressor therapy and/or inotropic or mechanical circulatory support, ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity—or resuscitated cardiac arrest and initiation of renal replacement therapy.
Protecting Organs with Rapid Startup Time
Reporting the fastest start-up time he’s ever experienced in his years of conducting clinical research, Principal Investigator Dr. Mikhail Kosiborod with Saint Luke’s Mid-America Heart Institute, stated recently, “The idea is you protect the vital organs, you prevent the disease from becoming more severe and thereby prevent development of severe complications and death. That’s the premise behind the study.” He continued, “The pandemic and the crisis is on everybody’s mind and everybody in the scientific community, including clinical scientists like myself, want to get answers as quickly as possible.”
The Research Site/Sponsor
A non-profit hospital network in the b-state Kansas City metro areas, Saint Luke’s Health System traces its history to its flagship hospital, Saint Luke’s Hospital of Kansas City, which was established in 1882. The health system employs over 12,000 and is the third largest employer in the Kansas City metro area.
St. Luke’s Mid-America Heart Institute offers the most comprehensive heart and vascular care in Kansas City. According to their website, they offer an array of cardiovascular services from disease prevention to heart transplantation. They note that they are ranked 42nd in the nation for cardiology and heart surgery by U.S. News & World Report, and they are the third hospital in the U.S. to achieve Comprehensive Cardiac Center certification from the Joint Commission.
Sold under the trade name of Farxiga (among others), this medication is used to treat type 2 Diabetes and with certain restrictions, type 1 diabetes. It is of the gliflozin class. Developed by Bristol-Myers in collaboration with AstraZeneca, it 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 glycemic 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.