Created at Source Raw Value Validated value
April 23, 2021, 12:31 a.m. usa

- subject enrolled in a study to investigate a treatment for covid-19 page 17 of 40 - subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc... - patients who are allergic to the investigational product or similar drugs (or any excipients) - subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type - subjects with known serious cardiovascular diseases, congenital long qt syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as new york heart association (nyha) class 3 or higher, or left ventricular ejection fraction (lvef) < 50%, qtcf > 450 ms - subjects with uncontrolled medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus) - known diagnosis of human immunodeficiency virus (hiv) , hepatitis c, active hepatitis b, treponema pallidum (testing is not mandatory) - alanine transaminase (alt) or aspartate transaminase (ast) > 5 times the upper limit of normal. - estimated glomerular filtration rate (egfr) < 30 ml/min - severe kidney disease requiring dialysis - subject unlikely to return for day 15 site visit for reasons other then remission - subject (or legally authorized representative) not willing or unable to provide informed consent - pregnant or breastfeeding

- subject enrolled in a study to investigate a treatment for covid-19 page 17 of 40 - subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc... - patients who are allergic to the investigational product or similar drugs (or any excipients) - subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type - subjects with known serious cardiovascular diseases, congenital long qt syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as new york heart association (nyha) class 3 or higher, or left ventricular ejection fraction (lvef) < 50%, qtcf > 450 ms - subjects with uncontrolled medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus) - known diagnosis of human immunodeficiency virus (hiv) , hepatitis c, active hepatitis b, treponema pallidum (testing is not mandatory) - alanine transaminase (alt) or aspartate transaminase (ast) > 5 times the upper limit of normal. - estimated glomerular filtration rate (egfr) < 30 ml/min - severe kidney disease requiring dialysis - subject unlikely to return for day 15 site visit for reasons other then remission - subject (or legally authorized representative) not willing or unable to provide informed consent - pregnant or breastfeeding