Status:
COMPLETED
Dapagliflozin in Respiratory Failure in Patients With COVID-19
Lead Sponsor:
Saint Luke's Health System
Collaborating Sponsors:
St. Luke's Hospital, Kansas City, Missouri
AstraZeneca
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States,...
Detailed Description
COVID-19 can lead to multiorgan failure, especially in high-risk patients. Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), favorably impacts many processes dysregulated during acut...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Male or female patients aged ≥18 years
- Currently hospitalized
- Hospital admission no more than 4 days prior to screening
- Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation
- Chest radiography or computerized tomography (CT) findings that, in the opinion of the investigator, are consistent with coronavirus disease 2019 (COVID-19)
- Blood oxygen saturation (SpO2) ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less)
- Medical history of at least one of the following:
- hypertension
- type 2 diabetes
- atherosclerotic cardiovascular disease
- heart failure (with either reduced or preserved left ventricular ejection fraction (LVEF))
- chronic kidney disease stage 3 to 4 (estimated glomerular filtration rate (eGFR) between 25 to 60 mL/min/1.73 m2)
- Key
Exclusion
- Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP))
- Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours
- Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator
- eGFR \<25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis
- Systolic blood pressure \<95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening
- History of type 1 diabetes mellitus
- History of diabetic ketoacidosis
- Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19
- Current treatment with any sodium-glucose cotransporter-2 inhibitor (SGLT2i) (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening
- Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry
- 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.
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT04350593
Start Date
April 22 2020
End Date
June 11 2021
Last Update
June 10 2022
Active Locations (95)
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1
Heart Group of the Eastern Shore
Fairhope, Alabama, United States, 36532
2
Baptist Hospital of Miami
Miami, Florida, United States, 33176
3
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
4
Loyola University
Maywood, Illinois, United States, 60153