Dapagliflozin in Respiratory Failure in Patients With COVID-19

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of dapagliflozin 10 milligrams versus placebo, given once daily for 30 days in addition to background local standard of care therapy, on reducing complications and all-cause mortality, or improving clinical recovery.

Key facts

Study ID

NCT04350593

Run by

Saint Luke's Health System

People needed

1250

Starts

2020-04-22

Expected to finish

2021-06-11

Last updated by the study team

2022-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Criteria:
• 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.

Where it is running

• Baptist Hospital of Miami — Miami, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Loyola University — Maywood, Illinois, United States
• Ascension - St. Vincent — Indianapolis, Indiana, United States
• Lahey Health — Burlington, Massachusetts, United States
• McLaren Health Care — Auburn Hills, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Clinical Trials Network of Tennessee — Memphis, Tennessee, United States
• DHR Health Institute for Research and Development — Edinburg, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Sentara Healthcare — Norfolk, Virginia, United States
• Clínica de Especialidades Villa María — Villa María, Province of Córdoba, Argentina
• Fundación Favaloro — Buenos Aires, Argentina
• Hospital Español — Buenos Aires, Argentina
• Heart Group of the Eastern Shore — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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