Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (cpap), or bilevel positive airway pressure (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 blood pressure \<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 sodium-glucose cotransporter-2 inhibitor (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.

1. respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (cpap), or bilevel positive airway pressure (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 blood pressure \<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 sodium-glucose cotransporter-2 inhibitor (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.

April 14, 2022, 11:30 p.m. usa

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.

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.

Nov. 16, 2021, 6:30 p.m. usa

respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, cpap, or 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 bp <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 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.

respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, cpap, or 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 bp <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 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.

Jan. 29, 2021, 12:31 a.m. usa

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.

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.

Oct. 26, 2020, 11:31 p.m. usa

1. severe covid-19: requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation 2. expected need for mechanical ventilation within the next 24 hours 3. expected survival of less than 24 hours at the time of presentation 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. currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for covid-19 8. history of diabetic ketoacidosis within last 6 months 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.

1. severe covid-19: requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation 2. expected need for mechanical ventilation within the next 24 hours 3. expected survival of less than 24 hours at the time of presentation 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. currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for covid-19 8. history of diabetic ketoacidosis within last 6 months 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.