Created at Source Raw Value Validated value
Jan. 14, 2022, 10 a.m. usa

hypersensitivity to olokizumab and / or other components of the study drug. contraindications to favipiravir or glucocorticosteroids or janus kinase inhibitors (baricitinib). signs of a severe or extremely severe course of covid-19, such as: altered level of consciousness, agitation, the need for / use of non-invasive ventilation (niv) / adaptive lung ventilation (alv) / extracorporeal membrane oxygenation (ecmo) at screening, hemodynamic instability eg systolic blood pressure < 90 mm hg or diastolic blood pressure < 60 mm hg and urine output less than 20 ml / hour, ct-3,4 stage on chest ct, signs of acute respiratory distress syndrome (ards), arterial blood lactate > 2 mmol / l, quick sequential organ failure assessment (qsofa) > 2 points. any of the following laboratory abnormalities: hemoglobin <80 g / l, absolute neutrophil count <0.5 x 10^9 / l, white blood cell count <2.0 x 10^9 / l, platelet count <50 x 10^9 / l, alanine transaminase (alt) and / or aspartate aminotransferase (ast) ≥ 3.0 x unl. severe renal failure: creatinine clearance < 30 ml / min. confirmed sepsis with non-covid-19 pathogens and procalcitonin levels > 0.5 ng / ml. prior hepatitis b and / or c virus infection. high probability of disease progression to death within the next 24 hours, regardless of therapy, by the opinion of the investigator. concomitant diseases associated with a poor prognosis. immunosuppressive therapy for organ transplantation. recent (less than 5 half-lives) or prescribed at screening: olokizumab (use or prescription prior to study randomization); biological drugs with immunosuppressive effects, including, but not limited to:interleukin 1 (il-1) inhibitors (anakinra, canakinumab), il-6 receptor inhibitors (tocilizumab, sarilumab, levilimab), il-17 (secukinumab, netakimab), tumor necrosis factor α inhibitors (tnfα) (infliximab, adalimumab, etanercept, etc.), anti-b-cell drugs, and others; immunosuppressive drugs (including, but not limited to): glucocorticoids in high doses (> 1 mg / kg prednisolone equivalent) orally or parenterally; janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. history of active tuberculosis or suspected active tuberculosis. simultaneous participation in another clinical trial. pregnancy or breastfeeding at screening; planning pregnancy during the entire study and within 3 months after the completion of treatment. any information from anamnesis that may lead to a complicated interpretation of the study results or create additional risk for the patient as a result of participation in the study. known (from history) or suspected abuse of alcohol, psychotropic drugs; drug addiction. subjects with a history or presence of any psychiatric disorder(s).

hypersensitivity to olokizumab and / or other components of the study drug. contraindications to favipiravir or glucocorticosteroids or janus kinase inhibitors (baricitinib). signs of a severe or extremely severe course of covid-19, such as: altered level of consciousness, agitation, the need for / use of non-invasive ventilation (niv) / adaptive lung ventilation (alv) / extracorporeal membrane oxygenation (ecmo) at screening, hemodynamic instability eg systolic blood pressure < 90 mm hg or diastolic blood pressure < 60 mm hg and urine output less than 20 ml / hour, ct-3,4 stage on chest ct, signs of acute respiratory distress syndrome (ards), arterial blood lactate > 2 mmol / l, quick sequential organ failure assessment (qsofa) > 2 points. any of the following laboratory abnormalities: hemoglobin <80 g / l, absolute neutrophil count <0.5 x 10^9 / l, white blood cell count <2.0 x 10^9 / l, platelet count <50 x 10^9 / l, alanine transaminase (alt) and / or aspartate aminotransferase (ast) ≥ 3.0 x unl. severe renal failure: creatinine clearance < 30 ml / min. confirmed sepsis with non-covid-19 pathogens and procalcitonin levels > 0.5 ng / ml. prior hepatitis b and / or c virus infection. high probability of disease progression to death within the next 24 hours, regardless of therapy, by the opinion of the investigator. concomitant diseases associated with a poor prognosis. immunosuppressive therapy for organ transplantation. recent (less than 5 half-lives) or prescribed at screening: olokizumab (use or prescription prior to study randomization); biological drugs with immunosuppressive effects, including, but not limited to:interleukin 1 (il-1) inhibitors (anakinra, canakinumab), il-6 receptor inhibitors (tocilizumab, sarilumab, levilimab), il-17 (secukinumab, netakimab), tumor necrosis factor α inhibitors (tnfα) (infliximab, adalimumab, etanercept, etc.), anti-b-cell drugs, and others; immunosuppressive drugs (including, but not limited to): glucocorticoids in high doses (> 1 mg / kg prednisolone equivalent) orally or parenterally; janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. history of active tuberculosis or suspected active tuberculosis. simultaneous participation in another clinical trial. pregnancy or breastfeeding at screening; planning pregnancy during the entire study and within 3 months after the completion of treatment. any information from anamnesis that may lead to a complicated interpretation of the study results or create additional risk for the patient as a result of participation in the study. known (from history) or suspected abuse of alcohol, psychotropic drugs; drug addiction. subjects with a history or presence of any psychiatric disorder(s).