Created at Source Raw Value Validated value
May 11, 2022, 6 a.m. usa

on extracorporeal membrane oxygenation (ecmo); spo2/fio2<100 while on respiratory support use of high dose of >1.0 mcg/kg/min of norepinephrine or need for rescue therapy with vasopressin; bacterial or fungal infection, except for mild cutaneous infection or sinus infection. asymptomatic bacteriuria or airway colonization of bacteria is not an exclusion criteria; pregnant or lactating; alanine aminotransferase (alt), aspartate aminotransaminase (ast) ≥5 times the upper limited of normal (uln), bilirubin >2 times the uln (unless previously diagnosed with gilbert's syndrome), or international normalised ratio (inr) outside of normal limits (unless prolonged due to taking anticoagulants) at screening estimated glomerular filtration rate (egfr) <30 ml/min; any condition which, in the opinion of the investigator, places the patient at unacceptable risk if they were to participate in the study; clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe hepatic impairment, active central nervous system (cns) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (hiv), active hepatitis b or c, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements; treatment with any immunosuppressive therapy other than corticosteroids within 30 days prior to screening; treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening, whichever is longer; prior treatment with the study drug (wp1122); known hypersensitivity to the inactive ingredients of the study drug (wp1122) or placebo. participation in another clinical study in less than 1 year (unless justified participation by the principal investigator)

on extracorporeal membrane oxygenation (ecmo); spo2/fio2<100 while on respiratory support use of high dose of >1.0 mcg/kg/min of norepinephrine or need for rescue therapy with vasopressin; bacterial or fungal infection, except for mild cutaneous infection or sinus infection. asymptomatic bacteriuria or airway colonization of bacteria is not an exclusion criteria; pregnant or lactating; alanine aminotransferase (alt), aspartate aminotransaminase (ast) ≥5 times the upper limited of normal (uln), bilirubin >2 times the uln (unless previously diagnosed with gilbert's syndrome), or international normalised ratio (inr) outside of normal limits (unless prolonged due to taking anticoagulants) at screening estimated glomerular filtration rate (egfr) <30 ml/min; any condition which, in the opinion of the investigator, places the patient at unacceptable risk if they were to participate in the study; clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe hepatic impairment, active central nervous system (cns) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (hiv), active hepatitis b or c, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements; treatment with any immunosuppressive therapy other than corticosteroids within 30 days prior to screening; treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening, whichever is longer; prior treatment with the study drug (wp1122); known hypersensitivity to the inactive ingredients of the study drug (wp1122) or placebo. participation in another clinical study in less than 1 year (unless justified participation by the principal investigator)