DARE-19 (Dapagliflozin in Respiratory failure in patients with COVID-19)

INTERVENTION: Intervention1: Dapagliflozin 10 mg: Patients will be randomized 1:1 to either dapagliflozin 10 mg or placebo once daily per oral use. Every attempt should be made to maintain patients on dapagliflozin 10 mg or matching placebo during the course of the study. The investigational product should be taken as soon as possible after randomization and then once daily in the morning, at approximately the same time every day, during the 30‐day treatment period Control Intervention1: Matching placebo: Patients will be randomized 1:1 to either dapagliflozin 10 mg or placebo once daily per oral use. Every attempt should be made to maintain patients on dapagliflozin 10 mg or matching placebo during the course of the study. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 ; 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) ; New or worsening congestive HFa during current hospitalization ; SECONDARY OUTCOME: To evaluate the net clinical benefit of dapagliflozin 10 mg compared to placebo in patients hospitalized with COVID‐19Timepoint: Hierarchical composite outcome measure (1): ; 1 Time to death from any cause ; 2 Time to new/worsened organ dysfunction (as defined in the primary outcome measure) ; 3 Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7‐point ordinal scalea) ; 4 Time to hospital discharge INCLUSION CRITERIA: Inclusion Criteria For inclusion in the study patients should fulfill the following criteria based on local regulations 1 Provision of informed consent prior to any study‐specific procedures 2 Male or female patients aged 18 years on the day consent given 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 Mild‐moderate disease SpO2 94 with low‐flow supplemental oxygen (5 liters or less) 8 Medical history of at least one of the following (a) hypertension (b) T2DM (c) atherosclerotic cardiovascular disease (d) heart failure (with either reduced or preserve