University of North Carolina at Chapel HillĬhapel Hill, North Carolina, United States, 27599 Saint Louis, Missouri, United States, 63110 Kansas City, Missouri, United States, 64111
Jackson, Mississippi, United States, 39216 Indianapolis, Indiana, United States, 46260īurlington, Massachusetts, United States, 01805Īuburn Hills, Michigan, United States, 48326 Note that use of rescue therapies including immune modulators, monoclonal antibody therapies, antiviral therapies, and other agents that are approved or being used through open-label compassionate/expanded use programs or in accordance with the local standard of care is permitted during the study.
#FARXIGA FREE 30 DAY TRIAL TRIAL#
Current treatment with any SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screeningĬurrent participation in another interventional clinical trial (with an investigational drug) that is not an observational registry. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19. Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening. eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis. Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator. Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours. Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, CPAP, or BiPAP). CKD stage 3 to 4 (eGFR between 25 to 60 mL/min/1.73 m2). heart failure (with either reduced or preserved LVEF). Medical history of at least one of the following: SpO2 ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less). Chest radiography or CT findings that, in the opinion of the investigator, are consistent with COVID-19. Confirmed SARS-CoV-2 infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation. Hospital admission no more than 4 days prior to screening. The safety data will be monitored by an Independent Data and Safety Monitoring Committee. An extended follow-up period of 60 days (after the 30-day treatment period) is included, in order to examine longer-term trajectory of recovery from COVID-19 among trial participants. The dual primary efficacy endpoints of the study are time to first event of either complications or death from any cause, and improved clinical recovery through 30 days of follow-up. The study assessments include only those that are absolutely critical for ensuring the safety of the patients, to measure efficacy outcomes, and collect biomarker data, so as not to place too high a burden on the study personnel and to minimize additional risk of exposure to SARS CoV-2. Patients will be treated for 30 days, with either dapagliflozin 10 mg daily or placebo, each to be given in addition to the usual standard of care in the participating hospital. The eligible patients should have risk factors for developing serious complications of COVID-19, including hypertension, T2DM, ASCVD, HF and/or CKD stage 3 to 4. The study population will include hospitalized patients with respiratory manifestations of COVID-19 of any duration, but without the need for mechanical ventilation. Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, favorably impacts many processes dysregulated during acute illness such as COVID-19, has significant cardio- and reno-protective benefits in cardiometabolic disease, and may provide similar organ protection in COVID-19. Why Should I Register and Submit Results?ĬOVID-19 can lead to multiorgan failure, especially in high-risk patients.
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