Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1.History of present illness (will be based on treating physicianâ??s opinion) <br/ > <br/ >a.Neurological and neurodevelopmental disorders. <br/ >b.Congenital heart disease <br/ >c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ > <br/ >2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ > <br/ >3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ > <br/ >4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ > <br/ >5.History of cirrhosis. <br/ > <br/ >6.A subject undergoing hemodialysis. <br/ > <br/ >7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ > <br/ >8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ > <br/ >9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ > <br/ >10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ > <br/ >11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ > <br/ >12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ > <br/ >13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ > <br/ >14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ >

1.History of present illness (will be based on treating physicianâ??s opinion) <br/ > <br/ >a.Neurological and neurodevelopmental disorders. <br/ >b.Congenital heart disease <br/ >c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ > <br/ >2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ > <br/ >3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ > <br/ >4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ > <br/ >5.History of cirrhosis. <br/ > <br/ >6.A subject undergoing hemodialysis. <br/ > <br/ >7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ > <br/ >8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ > <br/ >9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ > <br/ >10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ > <br/ >11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ > <br/ >12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ > <br/ >13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ > <br/ >14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ >

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

May 27, 2021, 12:45 a.m. oms

1.History of present illness (will be based on treating physicianâ??s opinion) <br/ > <br/ >a.Neurological and neurodevelopmental disorders. <br/ >b.Congenital heart disease <br/ >c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ > <br/ >2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ > <br/ >3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ > <br/ >4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ > <br/ >5.History of cirrhosis. <br/ > <br/ >6.A subject undergoing hemodialysis. <br/ > <br/ >7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ > <br/ >8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ > <br/ >9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ > <br/ >10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ > <br/ >11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ > <br/ >12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ > <br/ >13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ > <br/ >14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ >

1.History of present illness (will be based on treating physicianâ??s opinion) <br/ > <br/ >a.Neurological and neurodevelopmental disorders. <br/ >b.Congenital heart disease <br/ >c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ > <br/ >2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ > <br/ >3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ > <br/ >4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ > <br/ >5.History of cirrhosis. <br/ > <br/ >6.A subject undergoing hemodialysis. <br/ > <br/ >7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ > <br/ >8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ > <br/ >9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ > <br/ >10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ > <br/ >11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ > <br/ >12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ > <br/ >13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ > <br/ >14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ >