COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04350593

Mikhail Kosiborod, MD

Sheryl Windsor, swindsor@saint-lukes.org (PI email not reported)

2020-04-17

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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.

2

Saint Luke's Health System

18

None

Argentina;Brazil;Canada;India;Mexico;United Kingdom;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1250

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.;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.

None

Phase 3

[{"arm_notes": "", "treatment_id": 379, "treatment_name": "Dapagliflozin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]