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

1. inability to initiate study drug within 12 hours after randomization; 2. female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; 3. systolic blood pressure \<100 mmhg; 4. in shock or requiring pressor support; 5. respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); 6. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 × the upper limit of normal (uln); 7. total bilirubin \>2 × uln; 8. estimated glomerular filtration rate \<30 ml/min or receiving hemodialysis or hemofiltration; 9. moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; 10. any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; 11. decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. 12. use of cytochrome p450 (cyp) 2 subfamily c, polypeptide 8 (2c8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); 13. use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); 14. participation in another investigational study during the present study through the last visit (day 28); or 15. previous randomization in this study.

1. inability to initiate study drug within 12 hours after randomization; 2. female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; 3. systolic blood pressure \<100 mmhg; 4. in shock or requiring pressor support; 5. respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); 6. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 × the upper limit of normal (uln); 7. total bilirubin \>2 × uln; 8. estimated glomerular filtration rate \<30 ml/min or receiving hemodialysis or hemofiltration; 9. moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; 10. any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; 11. decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. 12. use of cytochrome p450 (cyp) 2 subfamily c, polypeptide 8 (2c8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); 13. use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); 14. participation in another investigational study during the present study through the last visit (day 28); or 15. previous randomization in this study.

June 9, 2023, noon usa

inability to initiate study drug within 12 hours after randomization; female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; systolic blood pressure <100 mmhg; in shock or requiring pressor support; respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); total bilirubin >2 × uln; estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. use of cytochrome p450 (cyp) 2 subfamily c, polypeptide 8 (2c8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); participation in another investigational study during the present study through the last visit (day 28); or previous randomization in this study.

inability to initiate study drug within 12 hours after randomization; female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; systolic blood pressure <100 mmhg; in shock or requiring pressor support; respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); total bilirubin >2 × uln; estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. use of cytochrome p450 (cyp) 2 subfamily c, polypeptide 8 (2c8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); participation in another investigational study during the present study through the last visit (day 28); or previous randomization in this study.

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

inability to initiate study drug within 12 hours after randomization; female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; systolic blood pressure <100 mmhg; in shock or requiring pressor support; respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); total bilirubin >2 × uln; estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. use of cytochrome p450 (cyp) 2c8 substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); participation in another investigational study during the present study through the last visit (day 28); or previous randomization in this study.

inability to initiate study drug within 12 hours after randomization; female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; systolic blood pressure <100 mmhg; in shock or requiring pressor support; respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); total bilirubin >2 × uln; estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. use of cytochrome p450 (cyp) 2c8 substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); participation in another investigational study during the present study through the last visit (day 28); or previous randomization in this study.

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

1. inability to initiate study drug within 12 hours after randomization; 2. female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; 3. systolic blood pressure <100 mmhg; 4. in shock or requiring pressor support; 5. respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); 6. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); 7. total bilirubin >2 × uln; 8. estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; 9. moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; 10. any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; 11. decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. 12. use of cytochrome p450 (cyp) 2c8 substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); 13. use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); 14. participation in another investigational study during the present study through the last visit (day 28); or 15. previous randomization in this study.

1. inability to initiate study drug within 12 hours after randomization; 2. female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; 3. systolic blood pressure <100 mmhg; 4. in shock or requiring pressor support; 5. respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); 6. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); 7. total bilirubin >2 × uln; 8. estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; 9. moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; 10. any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; 11. decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. 12. use of cytochrome p450 (cyp) 2c8 substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); 13. use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); 14. participation in another investigational study during the present study through the last visit (day 28); or 15. previous randomization in this study.