COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45521

DR VIJAY KUMAR CHOPRA

Vijay.Chopra@maxhealthcare.com

2020-09-16

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Inclusion Criteria <br/ >For inclusion in the study patients should fulfill the following criteria based on local regulations <br/ >1 Provision of informed consent prior to any study-specific procedures <br/ >2 Male or female patients aged 18 years on the day consent given <br/ >3 Currently hospitalized <br/ >4 Hospital admission no more than 4 days prior to screening <br/ >5 Confirmed SARS-CoV-2 infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation <br/ >6 Chest radiography or CT findings that, in the opinion of the investigator are consistent with COVID-19 <br/ >7 Mild-moderate disease SpO2 94 with low-flow supplemental oxygen (5 liters or less) <br/ >8 Medical history of at least one of the following <br/ >(a) hypertension <br/ >(b) T2DM <br/ >(c) atherosclerotic cardiovascular disease <br/ >(d) heart failure (with either reduced or preserved LVEF) <br/ >(e) CKD stage 3 to 4 <br/ >Note that the proportion of patients randomized without a confirmed SARS-CoV-2â??positive test will be closely monitored, and may be capped if it becomes greater than anticipated

Exclusion Criteria <br/ >Patients should not enter the study if any of the following exclusion criteria are fulfilled <br/ >1 Severe COVID-19 requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation <br/ >2 Expected need for mechanical ventilation with endotracheal intubation, non-invasive ventilation or continuous positive airway pressure (CPAP) within the next 24 hours <br/ >3 Anticipated transfer to another hospital facility which is not another study site within 72 hours <br/ >4 Expected survival of less than 24 hours at the time of presentation in the judgement of the Investigator <br/ >5 eGFR 25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis <br/ >6 Evidence 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 <br/ >7 Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening <br/ >8 History of type 1 diabetes mellitus <br/ >9 Currently receiving or has received in the last 14 days experimental immune modulators and/or monoclonal antibody therapies for COVID-19 <br/ >10 History of diabetic ketoacidosis <br/ >11 Current treatment with any SGLT2i (eg, dapagliflozin canagliflozin empagliflozin ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening <br/ >12 History of hypersensitivity to dapagliflozin <br/ >13 Any other condition that in the judgment of the investigator would jeopardize the patients 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 <br/ >14 Women of childbearing potential Current or planned pregnancy or currently lactating <br/ >a Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or post-menopausal <br/ >bPost-menopausal is defined as 12 consecutive months with no menses without an alternative medical cause <br/ >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. Acceptable birth control methods include: <br/ >Surgical sterilization (such as a hysterectomy or bilateral tubal ligation) <br/ >ii Progesterone hormonal contraceptives (birth control pills or implants) <br/ >iii Barrier methods (such as a condom or diaphragm) used with a spermicide <br/ >iv An intrauterine device <br/ >15 Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) <br/ >16 Previous enrolment in the present study (Note the study design allows 2 attempts to meet the randomization criteria after enrolment) <br/ >17 Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry

2

Saint Lukes Mid America Heart Institute

18

100

Argentina;Brazil;India;Mexico;United States

Moderate disease at enrollment

3: Moderate disease at enrollment

900

To determine whether dapagliflozin 10 mg is superior to placebo in reducing disease progression; complications; and all-cause mortality in patients hospitalized with COVID-19Timepoint: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up; defined as at least one of the following <br/ >Respiratory decompensation requiring initiation of invasive or non-invasive mechanical ventilation or continuous positive airway pressure (CPAP) treatment; and/or initiation of veno-venous extracorporeal membrane oxygenation (ECMO) <br/ >New or worsening congestive HFa during current hospitalization <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

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"}]