Dapagliflozin in Respiratory failure in patients with COVID-19

Phase 1

• Conditions: Respiratory Failure in patients with COVID-19; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001473-79-GB
• Lead Sponsor: Saint Luke’s Hospital of Kansas City, Kansas City, Missouri, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-24
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

For inclusion in the study patients should fulfil the following criteria based on local regulations:
1Provision of informed consent prior to any study specific procedures. The ICF process is described in Section 10.4
2Male or female patients aged =18 years on the day consent given
3Currently hospitalized
4Confirmed SARS-CoV-2 infection by laboratory testing <72h prior to randomization or strongly suspected on presentation
5Chest radiography or CT findings consistent with COVID-19, defined as: chest X-ray and/or CT scan demonstrating ground glass and/or fine reticular opacities with or without crazy-paving, multifocal organizing pneumonia and architectural distortion in a predominantly peripheral distribution
6Mild-moderate disease: SpO2=94% with low-flow supplemental oxygen (3 liters or less)
7Medical history of at least one of the following:
(a)hypertension
(b)T2DM
(c)atherosclerotic cardiovascular disease
(d)heart failure (with either reduced or preserved LVEF)
(e)CKD stage 3 to 4 (eGFR between 25 to 60 mL/min/1.73 m2)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

1Severe COVID-19: requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation
2Expected need for mechanical ventilation with endotracheal intubation, non-invasive ventilation, or continuous positive airway pressure (CPAP) within the next 24 hours
3Anticipated transfer to another hospital facility, which is not another study site, within 72 hours
4Expected survival of less than 24 hours at the time of presentation, in the judgement of the Investigator
5eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis
6Evidence of oliguria (urine output <500 mL in 24 hours or <0.5 mL/kg/hour) or serum creatinine =1.5x baseline pre-hospitalization value, if available at the time of screening
7Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening
8History of type 1 diabetes mellitus
9Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19**
10History of diabetic ketoacidosis within last 6 months
11Current treatment with any SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening
12History of hypersensitivity to dapagliflozin
13Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
14Women of childbearing potential: Current or planned pregnancy or currently lactating.
(a)Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or post-menopausal
(b)Post-menopausal is defined as 12 consecutive months with no menses without an alternative medical cause
(c)Women of childbearing potential, who are sexually active, must agree to use a medically accepted method of birth control for the duration of the study.
15Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
16Previous enrolment in the present study. (Note: the study design allows 2 attempts to meet the randomization criteria after enrolment.)
17Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified