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

- 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 - patient on ecmo at time of screening - clinical frailty scale above 3 (this frailty score is the patient status before first symptoms of covid-19 episode.) - 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 (> 20 mg methylprednisolone or equivalent) 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 - 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) - women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. woùmen of childbearing potential must consistently and correctly use (during the entire treatment period and 3 months after last reatment) 1 highly effective method for contraception.

- 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 - patient on ecmo at time of screening - clinical frailty scale above 3 (this frailty score is the patient status before first symptoms of covid-19 episode.) - 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 (> 20 mg methylprednisolone or equivalent) 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 - 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) - women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. woùmen of childbearing potential must consistently and correctly use (during the entire treatment period and 3 months after last reatment) 1 highly effective method for contraception.