Dapagliflozin in Respiratory Failure in Patients With COVID-19

• Status: Completed
• Trial end date: 2021-06-11
• Target enrollment: 0
• Participant gender: All

Summary

This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US, Brazil, Mexico, Argentina, India, Canada, and UK. The study is evaluating the effect of dapagliflozin 10 mg 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Luke's Health System
• Collaborators: AstraZeneca; George Clinical Pty Ltd; Saint Luke's Hospital of Kansas City
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

1. Provision of informed consent

2. Male or female patients aged ≥18 years

3. Currently hospitalized

4. Hospital admission no more than 4 days prior to screening

5. Confirmed SARS-CoV-2 infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation

6. Chest radiography or CT findings that, in the opinion of the investigator, are consistent with COVID-19

7. SpO2 ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less)

8. Medical history of at least one of the following:

1. hypertension

2. T2DM

3. atherosclerotic cardiovascular disease

4. heart failure (with either reduced or preserved LVEF)

5. CKD stage 3 to 4 (eGFR between 25 to 60 mL/min/1.73 m2)

Key Exclusion Criteria:

1. Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, CPAP, or BiPAP)

2. Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours

3. Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator

4. eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis

5. Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening

6. History of type 1 diabetes mellitus

7. History of diabetic ketoacidosis

8. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19

9. Current treatment with any SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening

10. 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.