Created at Source Raw Value Validated value
Sept. 11, 2021, 4 a.m. usa

- in the intensive care unit at the time of screening or prior to randomization - requiring mechanical ventilation at the time of screening or prior to randomization - has baseline estimated glomerular filtration rate < 30 ml/min/1.73m2 - has a history of kidney transplantation or hemodialysis treatment or receiving or expected to receive hemodialysis or peritoneal dialysis at screening and prior to randomization - is on mechanical ventilation - has a contraindication for mib-626 or its inert ingredients - has a diagnosis of lupus nephritis, polycystic kidney disease, other glomerular disease (other than diabetes) - has ast or alt > 3 times the upper limit of normal - has other medical condition which, in the opinion of the principal investigator, would jeopardize the safety of the study subject or impact the validity of the study results - will exclude patients, who are receiving or are enrolled in placebo-controlled intervention trials of anti-inflammatory or immunomodulatory agents, such as tocilizumab. occasional use of acetaminophen and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for fever or headache is permitted.

- in the intensive care unit at the time of screening or prior to randomization - requiring mechanical ventilation at the time of screening or prior to randomization - has baseline estimated glomerular filtration rate < 30 ml/min/1.73m2 - has a history of kidney transplantation or hemodialysis treatment or receiving or expected to receive hemodialysis or peritoneal dialysis at screening and prior to randomization - is on mechanical ventilation - has a contraindication for mib-626 or its inert ingredients - has a diagnosis of lupus nephritis, polycystic kidney disease, other glomerular disease (other than diabetes) - has ast or alt > 3 times the upper limit of normal - has other medical condition which, in the opinion of the principal investigator, would jeopardize the safety of the study subject or impact the validity of the study results - will exclude patients, who are receiving or are enrolled in placebo-controlled intervention trials of anti-inflammatory or immunomodulatory agents, such as tocilizumab. occasional use of acetaminophen and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for fever or headache is permitted.