Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Subjects will be excluded from the study based on the following criteria: <br/ > Have SpO2 less than or equal to 93% on room air at sea level or PaO2 or FiO2 less than300, respiratory rate greater than or equal to30 per minute, heart rate greater than or equal to125 per minute (FDA resource page, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (fda.gov)). <br/ > Estimated glomerular filtration rate (eGFR) less than30 ml per min <br/ > Serum total bilirubin greater than 1.5 x ULN (upper limit of normal) and AST and ALT greater than3 x ULN <br/ > Subjects with significant cardiovascular disease as following: <br/ > i. heart failure NYHA class greater than or equal to3 <br/ > ii. left ventricular ejection fraction less than 50 percent <br/ > iii. those with a history of cardiac arrhythmias, including long QT syndrome. <br/ > Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen. <br/ > Have known allergies to any of the components used in the formulation of the interventions. <br/ > Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization. <br/ > Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]). <br/ > Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days. <br/ > Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. <br/ > Subjects with myopathy. <br/ > Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening. <br/ > Have participated, within the last 30 days, 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. <br/ > Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. <br/ > Subject taking an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. <br/ > Are investigator site personnel directly affiliated with this study. <br/ > <br/ >

Subjects will be excluded from the study based on the following criteria: <br/ > Have SpO2 less than or equal to 93% on room air at sea level or PaO2 or FiO2 less than300, respiratory rate greater than or equal to30 per minute, heart rate greater than or equal to125 per minute (FDA resource page, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (fda.gov)). <br/ > Estimated glomerular filtration rate (eGFR) less than30 ml per min <br/ > Serum total bilirubin greater than 1.5 x ULN (upper limit of normal) and AST and ALT greater than3 x ULN <br/ > Subjects with significant cardiovascular disease as following: <br/ > i. heart failure NYHA class greater than or equal to3 <br/ > ii. left ventricular ejection fraction less than 50 percent <br/ > iii. those with a history of cardiac arrhythmias, including long QT syndrome. <br/ > Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen. <br/ > Have known allergies to any of the components used in the formulation of the interventions. <br/ > Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization. <br/ > Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]). <br/ > Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days. <br/ > Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. <br/ > Subjects with myopathy. <br/ > Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening. <br/ > Have participated, within the last 30 days, 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. <br/ > Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. <br/ > Subject taking an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. <br/ > Are investigator site personnel directly affiliated with this study. <br/ > <br/ >