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

* pregnant and/or lactating women * patients included in any other interventional trial * use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening * any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to: * septic shock as defined by systolic blood pressure (sbp) \< 90 mmhg or diastolic blood pressure (dbp) of \< 60 mmhg; * multiple organ failure; * are moribund irrespective of the provision of treatments; * any significant bleeding disorder or vasculitis; * any serious, nonhealing wound, peptic ulcer or bone fracture; * liver cirrhosis; * history of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; * severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \<30ml/min/1.73m2; * ards risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. * any thromboembolic event within the past 3 months; * symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \> class ii as per new york heart association (nyha) classification; * history of autonomic disorders or uncontrolled hypotension * hypersensitivity to drug products containing polyethylene glycol (peg) * any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study

* pregnant and/or lactating women * patients included in any other interventional trial * use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening * any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to: * septic shock as defined by systolic blood pressure (sbp) \< 90 mmhg or diastolic blood pressure (dbp) of \< 60 mmhg; * multiple organ failure; * are moribund irrespective of the provision of treatments; * any significant bleeding disorder or vasculitis; * any serious, nonhealing wound, peptic ulcer or bone fracture; * liver cirrhosis; * history of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; * severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \<30ml/min/1.73m2; * ards risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. * any thromboembolic event within the past 3 months; * symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \> class ii as per new york heart association (nyha) classification; * history of autonomic disorders or uncontrolled hypotension * hypersensitivity to drug products containing polyethylene glycol (peg) * any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study

Dec. 2, 2022, 4 p.m. usa

pregnant and/or lactating women patients included in any other interventional trial use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to: septic shock as defined by systolic blood pressure (sbp) < 90 mmhg or diastolic blood pressure (dbp) of < 60 mmhg; multiple organ failure; are moribund irrespective of the provision of treatments; any significant bleeding disorder or vasculitis; any serious, nonhealing wound, peptic ulcer or bone fracture; liver cirrhosis; history of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate <30ml/min/1.73m2; ards risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. any thromboembolic event within the past 3 months; symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia > class ii as per new york heart association (nyha) classification; history of autonomic disorders or uncontrolled hypotension hypersensitivity to drug products containing polyethylene glycol (peg) any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study

pregnant and/or lactating women patients included in any other interventional trial use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to: septic shock as defined by systolic blood pressure (sbp) < 90 mmhg or diastolic blood pressure (dbp) of < 60 mmhg; multiple organ failure; are moribund irrespective of the provision of treatments; any significant bleeding disorder or vasculitis; any serious, nonhealing wound, peptic ulcer or bone fracture; liver cirrhosis; history of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate <30ml/min/1.73m2; ards risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. any thromboembolic event within the past 3 months; symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia > class ii as per new york heart association (nyha) classification; history of autonomic disorders or uncontrolled hypotension hypersensitivity to drug products containing polyethylene glycol (peg) any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study

Nov. 19, 2021, 7:30 p.m. usa

pregnant and/or lactating women patients included in any other interventional trial body mass index (bmi) > 35 use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening any concurrent serious medical condition or concomitant medication that would preclude participation in the study known history of human immunodeficiency virus and/or hepatitis (acute or chronic) severe renal insufficiency or end-stage renal disease recent (within past 2 months) major surgery or central venous access device placement any thromboembolic event within the past 3 months symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia > class ii as per new york heart association (nyha) classification history of autonomic disorders or uncontrolled hypotension hypersensitivity to drug products containing polyethylene glycol (peg) any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study

pregnant and/or lactating women patients included in any other interventional trial body mass index (bmi) > 35 use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ecmo) at screening any concurrent serious medical condition or concomitant medication that would preclude participation in the study known history of human immunodeficiency virus and/or hepatitis (acute or chronic) severe renal insufficiency or end-stage renal disease recent (within past 2 months) major surgery or central venous access device placement any thromboembolic event within the past 3 months symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia > class ii as per new york heart association (nyha) classification history of autonomic disorders or uncontrolled hypotension hypersensitivity to drug products containing polyethylene glycol (peg) any other condition which the principal investigator feels may jeopardize the safety of the patient or the objectives of the study