Created at Source Raw Value Validated value
Dec. 11, 2020, 12:31 a.m. usa

- < 18 years of age. - evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury). - known active inflammatory bowel disease. - known active, untreated diverticulitis. - known untreated bacteremia. - 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). - known hypersensitivity to the clazakizumab. - vulnerable subjects will not be excluded. this study is designed to include any patients deemed at risk for imminent death, and the opportunity to enroll will not be withheld provided the subject meets the above inclusion and exclusion criteria.

- < 18 years of age. - evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers (for example severe anoxic brain injury). - known active inflammatory bowel disease. - known active, untreated diverticulitis. - known untreated bacteremia. - 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). - known hypersensitivity to the clazakizumab. - vulnerable subjects will not be excluded. this study is designed to include any patients deemed at risk for imminent death, and the opportunity to enroll will not be withheld provided the subject meets the above inclusion and exclusion criteria.