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

- 1. evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury) - 2. known active inflammatory bowel disease - 3. known active, untreated diverticulitis - 4. known untreated bacteremia - 5. pregnancy. (the protocol will exclude pregnant subjects given the lack of overall data on use of clazakizumab in pregnancy however the study team would consider a protocol revision should more than 3 potential pregnant study subjects be excluded on this basis). - 6. known hypersensitivity to the clazakizumab - 7. use of other il-6 inhibitor investigational drugs at the time of enrollment

- 1. evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury) - 2. known active inflammatory bowel disease - 3. known active, untreated diverticulitis - 4. known untreated bacteremia - 5. pregnancy. (the protocol will exclude pregnant subjects given the lack of overall data on use of clazakizumab in pregnancy however the study team would consider a protocol revision should more than 3 potential pregnant study subjects be excluded on this basis). - 6. known hypersensitivity to the clazakizumab - 7. use of other il-6 inhibitor investigational drugs at the time of enrollment