Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

respiratory failure at time of screening due to covid-19 known medical resuscitation within 14 days of randomization pregnant or breast feeding suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) alanine aminotransferase (alt), aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected within 24 hours at screening (per local lab) uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). requires treatment with proton-pump inhibitors (ppis; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving ppis who switch to h2-receptor antagonists or antacids are eligible for enrollment in this study received oral antirejection or immunomodulatory drugs (eg, anticytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study

respiratory failure at time of screening due to covid-19 known medical resuscitation within 14 days of randomization pregnant or breast feeding suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) alanine aminotransferase (alt), aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected within 24 hours at screening (per local lab) uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). requires treatment with proton-pump inhibitors (ppis; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving ppis who switch to h2-receptor antagonists or antacids are eligible for enrollment in this study received oral antirejection or immunomodulatory drugs (eg, anticytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study

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

1. respiratory failure at time of screening due to covid-19 2. known medical resuscitation within 14 days of randomization 3. pregnant or breast feeding 4. suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) 5. alanine aminotransferase (alt), aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected within 24 hours at screening (per local lab) 6. uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll 7. treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 8. requires treatment with proton-pump inhibitors (ppis; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving ppis who switch to h2-receptor antagonists or antacids are eligible for enrollment in this study 9. received oral antirejection or immunomodulatory drugs (eg, anticytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study

1. respiratory failure at time of screening due to covid-19 2. known medical resuscitation within 14 days of randomization 3. pregnant or breast feeding 4. suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) 5. alanine aminotransferase (alt), aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected within 24 hours at screening (per local lab) 6. uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll 7. treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 8. requires treatment with proton-pump inhibitors (ppis; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving ppis who switch to h2-receptor antagonists or antacids are eligible for enrollment in this study 9. received oral antirejection or immunomodulatory drugs (eg, anticytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study