Created at Source Raw Value Validated value
March 15, 2022, 3:30 p.m. eu

1. Known hypersensitivity or allergy to colchicine 2. Pregnant or currently breast feeding 3. Participation in any other clinical trial of an experimental treatment for COVID-19. Convalescent plasma, dexamethasone and remdesivir are allowed in this study. 4. Concurrent treatment with other experimental agents within 5 half-lives of the last dose of the investigational or experimental drug to study drug dosing under this protocol (except standard of care). Remdesivir, dexamethasone and convalescent plasma are allowed in the study. 5. Requiring ventilation + additional organ support – pressors, RRT, ECMO (WHO Ordinal Scale for Clinical Improvement – Score of 7). NOTE: short term (PRN) use of pressors is allowed. 6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >3 X upper limit of normal (ULN) 7. Total bilirubin > ULN 8. Creatinine clearance < 60 mL/min 9. 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 10. Moderate to severe renal impairment 11. Hepatic impairment 12. History of hepatitis- (Hepatitis B and C) NOTE: treated and controlled hepatitis C is allowed. 13. Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, gastrointestinal, hepatic, or central nervous system, or in PI’s opinion other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk. 14. 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. Pregnant or currently breast feeding 3. Participation in any other clinical trial of an experimental treatment for COVID-19. Convalescent plasma, dexamethasone and remdesivir are allowed in this study. 4. Concurrent treatment with other experimental agents within 5 half-lives of the last dose of the investigational or experimental drug to study drug dosing under this protocol (except standard of care). Remdesivir, dexamethasone and convalescent plasma are allowed in the study. 5. Requiring ventilation + additional organ support – pressors, RRT, ECMO (WHO Ordinal Scale for Clinical Improvement – Score of 7). NOTE: short term (PRN) use of pressors is allowed. 6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >3 X upper limit of normal (ULN) 7. Total bilirubin > ULN 8. Creatinine clearance < 60 mL/min 9. 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 10. Moderate to severe renal impairment 11. Hepatic impairment 12. History of hepatitis- (Hepatitis B and C) NOTE: treated and controlled hepatitis C is allowed. 13. Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, gastrointestinal, hepatic, or central nervous system, or in PI’s opinion other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk. 14. 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.