Created at Source Raw Value Validated value
June 12, 2021, 12:45 a.m. oms

1. Treating team deems enrolment in the study is not in the best interests of the participant. 2. Death is deemed to be imminent and inevitable within the next 24 hours. 3. Either the patient or their primary treating clinician is not committed to active treatment. 4. Current treatment with colchicine. 5. Known severe allergic response (e.g. profuse diarrhoea) to colchicine. 6. Potential severe drug interaction with colchicine. 7. Receiving concurrent Anakinra. 8. End-stage renal disease with eGFR less than or equal to 30 ml/min/m2. 9. Acute or chronic hepatitis, with liver enzyme abnormalities > 5 x ULN at baseline. 10. Known HIV infection or other immunocompromised status (with the exception of steroids including dexamethasone and tocilizumab). 11. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

1. Treating team deems enrolment in the study is not in the best interests of the participant. 2. Death is deemed to be imminent and inevitable within the next 24 hours. 3. Either the patient or their primary treating clinician is not committed to active treatment. 4. Current treatment with colchicine. 5. Known severe allergic response (e.g. profuse diarrhoea) to colchicine. 6. Potential severe drug interaction with colchicine. 7. Receiving concurrent Anakinra. 8. End-stage renal disease with eGFR less than or equal to 30 ml/min/m2. 9. Acute or chronic hepatitis, with liver enzyme abnormalities > 5 x ULN at baseline. 10. Known HIV infection or other immunocompromised status (with the exception of steroids including dexamethasone and tocilizumab). 11. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.