OVERLAND PARK, Kan., April 30, 2020 /PRNewswire/ -- George Clinical, a global scientifically-backed clinical research organization, is collaborating with Saint Luke's Mid America Heart Institute on a new study which will explore whether dapagliflozin (an SGLT inhibitor) can prevent disease progression in patients hospitalized with COVID-19 and at high risk for complications due to pre-existing cardio metabolic risk factors. The study will include 900 patients globally with approximately half of those coming from the United States and the remainder from other countries with high prevalence of COVID-19.
Informed consent can be captured via virtual signing, camera phone imagery and witnessing to ensure social distancing and reduce risk of spreading of the virus among staff and patients. Remote clinical site monitoring and continuous site personnel training will be in place in each country. Electronic data capture powered by collaboration between Protocol First and the George Clinical data sciences team delivered best-in-class technology enabling the rapid study start-up.
"The start-up of this study took less than three weeks, which is amazing for an international project of this magnitude," stated George Clinical Chief Business Officer Sean Hart. "We were able to break down barriers showing strong global support and the kind of nimble mentality we all need to successfully manage research during this pandemic."
Mikhail Kosiborod, MD, a cardiologist at Saint Luke's Mid America Heart Institute and Vice President of Research at Saint Luke's Health System, is principal investigator of the study referred to as DARE-19. Since patients with pre-existing health conditions are at greater risk for moderate to severe complications from SARS-CoV-2 infection, studies that evaluate potential protective measures are critical for both individual and public health outcomes during a time of pandemic.
"A study focusing on hospitalized patients who are at higher risk for severe disease due to pre-existing cardio metabolic disease offers us the path to better understand what treatments protect the body during infection and assist them in their overall battle with the SARS-CoV-2 virus," said Chief Medical Officer Maria Ali of George Clinical.
This study targets countries with the current highest level of COVID-19 load on their healthcare systems. Study enrollment has begun in the Kansas City metropolitan area at Saint Luke's Hospital of Kansas City and other multiple other hospitals around the nation. The Kansas City area is also home to the U.S. headquarters of George Clinical.
"The fact that we could progress from concept to 'first patient in' within 30 days is remarkable," said Global Project Director Emily Akin. "I also want to acknowledge a high level of support from governmental regulatory agencies and local ethics committees whom helped move the study into recruitment."
The partnership between Saint Luke's and George Clinical, along with a key pharmaceutical industry partner, uses cutting-edge technology which accomplishes investigator training, study initiation virtually and remote monitoring techniques. George Clinical scientific leadership, operational infrastructure and data science teams are actively advising stakeholders on numerous potential COVID-19 vaccine and treatment studies.
About George Clinical George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With 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.