Created at Source Raw Value Validated value
Oct. 26, 2020, 11:31 p.m. usa

- requirement of oxygen supplementation >8l nasal cannula - pregnancy - known hypersensitivity to colchicine - patient currently in shock or with hemodynamic instability requiring pressors - history of cirrhosis - alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5x upper limit of normal (uln) - patients with severe renal disease, crcl <30ml/min - patients requiring invasive mechanical ventilation at screening or clinical estimation that the patient will require mechanical respiratory support within 24 hours - patient is currently taking colchicine for other indications (gout or familial mediterranean fever) - patient received remdesivir, sarilumab, tociluzimab, lopinavir/ritonavir or other immunomodulator given for covid-19 treatment (note: convalescent plasma infusion is not an exclusion) - patient is on (and cannot discontinue) a strong cyp3a4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate cyp3a4 inhbitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a p-gp inhibitor (eg cyclosporine, ranolazine) - patient is undergoing chemotherapy for cancer - patient is considered by the investigator, for any reason, to be unsuitable candidate for the study

- requirement of oxygen supplementation >8l nasal cannula - pregnancy - known hypersensitivity to colchicine - patient currently in shock or with hemodynamic instability requiring pressors - history of cirrhosis - alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5x upper limit of normal (uln) - patients with severe renal disease, crcl <30ml/min - patients requiring invasive mechanical ventilation at screening or clinical estimation that the patient will require mechanical respiratory support within 24 hours - patient is currently taking colchicine for other indications (gout or familial mediterranean fever) - patient received remdesivir, sarilumab, tociluzimab, lopinavir/ritonavir or other immunomodulator given for covid-19 treatment (note: convalescent plasma infusion is not an exclusion) - patient is on (and cannot discontinue) a strong cyp3a4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate cyp3a4 inhbitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a p-gp inhibitor (eg cyclosporine, ranolazine) - patient is undergoing chemotherapy for cancer - patient is considered by the investigator, for any reason, to be unsuitable candidate for the study