Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

-Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product. -mechanical ventilation > 24 h at randomization -clinical frailty scale above 3 -active bacterial or fungal infection -unlikely to survive beyond 48h -neutrophil count below 1500 cells/microliter -platelets below 50.000/microliter -Patients enrolled in another investigational drug study -patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) for COVID-19 unrelated disorder -patients on immunosuppressant or immunomodulatory drugs -patients on current anti-IL1 or anti-IL6 treatment -signs of active tuberculosis -serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml -history of (non-iatrogenic) bowel perforation or diverticulitis - Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)

-Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product. -mechanical ventilation > 24 h at randomization -clinical frailty scale above 3 -active bacterial or fungal infection -unlikely to survive beyond 48h -neutrophil count below 1500 cells/microliter -platelets below 50.000/microliter -Patients enrolled in another investigational drug study -patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) for COVID-19 unrelated disorder -patients on immunosuppressant or immunomodulatory drugs -patients on current anti-IL1 or anti-IL6 treatment -signs of active tuberculosis -serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml -history of (non-iatrogenic) bowel perforation or diverticulitis - Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)