Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor 4) Current serious or uncontrolled medical condition or abnormality of clinical 5) Untreated systemic bacterial, fungal, viral, or other infection 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB 7) Known HIV regardless of immunological status 8) Known HBsAg and/or anti-HCV positive 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy For more details check the protocol

1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor 4) Current serious or uncontrolled medical condition or abnormality of clinical 5) Untreated systemic bacterial, fungal, viral, or other infection 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB 7) Known HIV regardless of immunological status 8) Known HBsAg and/or anti-HCV positive 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy For more details check the protocol