Created at Source Raw Value Validated value
March 27, 2022, 4 p.m. usa

subjects are excluded from the study if any of the following criteria apply: alt/ast > 3 times the upper limit of normal. serum total bilirubin > 1.5 x uln (upper limit of normal) estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) pregnancy or breast feeding anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. allergy to any study medication. received monoclonal antibody, convalescent plasma, or intravenous immunoglobulin [ivig]) for covid-19 withing 14 days of screening. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. subjects with active myopathy is admitted to intensive care units at randomization

subjects are excluded from the study if any of the following criteria apply: alt/ast > 3 times the upper limit of normal. serum total bilirubin > 1.5 x uln (upper limit of normal) estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) pregnancy or breast feeding anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. allergy to any study medication. received monoclonal antibody, convalescent plasma, or intravenous immunoglobulin [ivig]) for covid-19 withing 14 days of screening. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. subjects with active myopathy is admitted to intensive care units at randomization

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

subjects are excluded from the study if any of the following criteria apply: alt/ast > 3 times the upper limit of normal. serum total bilirubin > 1.5 x uln (upper limit of normal) estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) pregnancy or breast feeding anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. allergy to any study medication. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. subjects with myopathy is admitted to intensive care units at randomization

subjects are excluded from the study if any of the following criteria apply: alt/ast > 3 times the upper limit of normal. serum total bilirubin > 1.5 x uln (upper limit of normal) estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) pregnancy or breast feeding anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. allergy to any study medication. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. subjects with myopathy is admitted to intensive care units at randomization

Aug. 26, 2021, 7:30 p.m. usa

subjects are excluded from the study if any of the following criteria apply: 1. alt/ast > 3 times the upper limit of normal. 2. serum total bilirubin > 1.5 x uln (upper limit of normal) 3. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). 4. subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. 5. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). 6. lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) 7. pregnancy or breast feeding 8. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 9. allergy to any study medication. 10. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. 11. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. 12. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 13. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). 14. subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. 15. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 16. subjects with myopathy 17. is admitted to intensive care units at randomization

subjects are excluded from the study if any of the following criteria apply: 1. alt/ast > 3 times the upper limit of normal. 2. serum total bilirubin > 1.5 x uln (upper limit of normal) 3. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). 4. subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. 5. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 10^3/μl). 6. lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 10^3/μl) 7. pregnancy or breast feeding 8. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 9. allergy to any study medication. 10. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. 11. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. 12. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 13. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). 14. subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. 15. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 16. subjects with myopathy 17. is admitted to intensive care units at randomization

Aug. 17, 2021, 6 p.m. usa

1. alt/ast > 3 times the upper limit of normal. 2. serum total bilirubin > 1.5 x uln (upper limit of normal) 3. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). 4. subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. 5. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 103/μl). 6. lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 103/μl) 7. pregnancy or breast feeding 8. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 9. allergy to any study medication. 10. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. 11. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. 12. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 13. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). 14. subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. 15. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 16. subjects with myopathy 17. is admitted to intensive care units at randomization

1. alt/ast > 3 times the upper limit of normal. 2. serum total bilirubin > 1.5 x uln (upper limit of normal) 3. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). 4. subjects with significant cardiovascular disease as following: i. heart failure nyha class ≥3 ii. left ventricular ejection fraction <50% iii. those with a history of cardiac arrhythmias, including long qt syndrome. 5. neutropenia (absolute neutrophil count <1000 cells/μl) (<1.0 x 103/μl). 6. lymphopenia (absolute lymphocyte count <200 cells/μl) (<0.20 x 103/μl) 7. pregnancy or breast feeding 8. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 9. allergy to any study medication. 10. received convalescent plasma or intravenous immunoglobulin [ivig]) for covid-19. 11. has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg per day or equivalent) within 2 weeks of screening. 12. suspected serious, active bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 13. have a history of vte (deep vein thrombosis [dvt] or pulmonary embolism [pe]) within 12 weeks prior to screening or have a history of recurrent (>1) vte (dvt/pe). 14. subject taking or had taken an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. 15. have participated, within the last 30 days before dosing, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 16. subjects with myopathy 17. is admitted to intensive care units at randomization