Phase 3
N=1,250
Dapagliflozin in Respiratory Failure in Patients With COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04350593 ↗Enrolled (actual)
1,250
Serious AEs
12.8%
Results posted
Apr 2022
Primary outcome: Primary: Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause. — 12.4; 15.6 Patients with events/100 pt-mos at risk
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapagliflozin 10 milligram (mg) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Saint Luke's Health System
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause. |
12.4; 15.6 | — |
| PRIMARY Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. |
547; 532 | — |
| SECONDARY Time to Hospital Discharge |
5; 6 | — |
| SECONDARY Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) |
27.8; 27.4 | — |
| SECONDARY Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) |
27.5; 27.1 | — |
| SECONDARY Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause |
8.2; 11.2 | — |
| SECONDARY Time to Death From Any Cause |
6.8; 9.0 | — |
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, 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04350593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.