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

inclusion criteria: * age 18-80 years * meets 'berlin criteria' for diagnosis of moderate to severe ards for a minimum of 4 hours * less than 48 hours on a ventilator after meeting criteria for diagnosis of ards * sars-cov-2 (proven by rt-pcr assay) with radiographic infiltrates * pao2/fio2 \< 250 * positive end-expiratory airway pressure (peep) \>5 cm h20 * elevated c-reactive protein (above laboratory upper limit of normal) * meets organ function requirements, including left ventricular ejection fraction (lvef) \>35% ( as defined below) * off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of sars-cov-2 \[e.g., remdesivir\] are permitted * voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the covid-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study). * adequate organ function is defined as: * renal: calculated estimated glomerular filtration rate \>30 ml/min/1.73 m2 (on chemistry panel) * hepatic: bilirubin \<3x upper limit of normal (uln) and ast, alt and alkaline phosphatase \<5x uln * cardiac: absence of uncontrolled arrhythmia and lvef \>35%

inclusion criteria: * age 18-80 years * meets 'berlin criteria' for diagnosis of moderate to severe ards for a minimum of 4 hours * less than 48 hours on a ventilator after meeting criteria for diagnosis of ards * sars-cov-2 (proven by rt-pcr assay) with radiographic infiltrates * pao2/fio2 \< 250 * positive end-expiratory airway pressure (peep) \>5 cm h20 * elevated c-reactive protein (above laboratory upper limit of normal) * meets organ function requirements, including left ventricular ejection fraction (lvef) \>35% ( as defined below) * off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of sars-cov-2 \[e.g., remdesivir\] are permitted * voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the covid-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study). * adequate organ function is defined as: * renal: calculated estimated glomerular filtration rate \>30 ml/min/1.73 m2 (on chemistry panel) * hepatic: bilirubin \<3x upper limit of normal (uln) and ast, alt and alkaline phosphatase \<5x uln * cardiac: absence of uncontrolled arrhythmia and lvef \>35%

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

inclusion criteria: - age 18-80 years - meets 'berlin criteria' for diagnosis of moderate to severe ards for a minimum of 4 hours - less than 48 hours on a ventilator after meeting criteria for diagnosis of ards - sars-cov-2 (proven by rt-pcr assay) with radiographic infiltrates - pao2/fio2 < 250 - positive end-expiratory airway pressure (peep) >5 cm h20 - elevated c-reactive protein (above laboratory upper limit of normal) - meets organ function requirements, including left ventricular ejection fraction (lvef) >35% ( as defined below) - off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of sars-cov-2 [e.g., remdesivir] are permitted - voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the covid-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study). - adequate organ function is defined as: - renal: calculated estimated glomerular filtration rate >30 ml/min/1.73 m2 (on chemistry panel) - hepatic: bilirubin <3x upper limit of normal (uln) and ast, alt and alkaline phosphatase <5x uln - cardiac: absence of uncontrolled arrhythmia and lvef >35%

inclusion criteria: - age 18-80 years - meets 'berlin criteria' for diagnosis of moderate to severe ards for a minimum of 4 hours - less than 48 hours on a ventilator after meeting criteria for diagnosis of ards - sars-cov-2 (proven by rt-pcr assay) with radiographic infiltrates - pao2/fio2 < 250 - positive end-expiratory airway pressure (peep) >5 cm h20 - elevated c-reactive protein (above laboratory upper limit of normal) - meets organ function requirements, including left ventricular ejection fraction (lvef) >35% ( as defined below) - off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of sars-cov-2 [e.g., remdesivir] are permitted - voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the covid-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study). - adequate organ function is defined as: - renal: calculated estimated glomerular filtration rate >30 ml/min/1.73 m2 (on chemistry panel) - hepatic: bilirubin <3x upper limit of normal (uln) and ast, alt and alkaline phosphatase <5x uln - cardiac: absence of uncontrolled arrhythmia and lvef >35%