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

1. known hypersensitivity or allergy to colchicine 2. participation in any other clinical trial of an experimental treatment for covid-19 3. concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited \< 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. 4. requiring mechanical ventilation at screening 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2 x upper limit of normal (uln) 6. total bilirubin \> uln 7. creatinine clearance \< 60 ml/min 8. documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices 9. moderate to severe renal impairment 10. hepatic impairment 11. positive for hbsag, or hcv antibodies at screening 12. any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk 13. participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.

1. known hypersensitivity or allergy to colchicine 2. participation in any other clinical trial of an experimental treatment for covid-19 3. concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited \< 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. 4. requiring mechanical ventilation at screening 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2 x upper limit of normal (uln) 6. total bilirubin \> uln 7. creatinine clearance \< 60 ml/min 8. documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices 9. moderate to severe renal impairment 10. hepatic impairment 11. positive for hbsag, or hcv antibodies at screening 12. any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk 13. participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.

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

known hypersensitivity or allergy to colchicine participation in any other clinical trial of an experimental treatment for covid-19 concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. requiring mechanical ventilation at screening alanine aminotransferase (alt) or aspartate aminotransferase (ast) >2 x upper limit of normal (uln) total bilirubin > uln creatinine clearance < 60 ml/min documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices moderate to severe renal impairment hepatic impairment positive for hbsag, or hcv antibodies at screening any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.

known hypersensitivity or allergy to colchicine participation in any other clinical trial of an experimental treatment for covid-19 concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. requiring mechanical ventilation at screening alanine aminotransferase (alt) or aspartate aminotransferase (ast) >2 x upper limit of normal (uln) total bilirubin > uln creatinine clearance < 60 ml/min documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices moderate to severe renal impairment hepatic impairment positive for hbsag, or hcv antibodies at screening any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.

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

1. known hypersensitivity or allergy to colchicine 2. participation in any other clinical trial of an experimental treatment for covid-19 3. concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. 4. requiring mechanical ventilation at screening 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >2 x upper limit of normal (uln) 6. total bilirubin > uln 7. creatinine clearance < 60 ml/min 8. documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices 9. moderate to severe renal impairment 10. hepatic impairment 11. positive for hbsag, or hcv antibodies at screening 12. any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk 13. participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.

1. known hypersensitivity or allergy to colchicine 2. participation in any other clinical trial of an experimental treatment for covid-19 3. concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against covid-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) remdesivir and convalescent plasma is allowed as standard of care. 4. requiring mechanical ventilation at screening 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >2 x upper limit of normal (uln) 6. total bilirubin > uln 7. creatinine clearance < 60 ml/min 8. documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices 9. moderate to severe renal impairment 10. hepatic impairment 11. positive for hbsag, or hcv antibodies at screening 12. any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk 13. participants must agree to refrain from prolonged exposure to the sun or agree to use at least spf 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with veru-111.