Created at Source Raw Value Validated value
June 25, 2024, noon usa

* presence of any of the following laboratory abnormalities: absolute neutrophil counts \<0,5 х 10\^9/l white blood cell count \< 2 х 10\^9/l, platelet count \< 50 х 10\^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) * kidney injury with creatinine clearance \<30 ml/min. * hypersensitivity to okz, and/or its components. * septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). * estimated survival of less than 24 hours regardless of treatment. * history of perforation of the gastrointestinal tract, history of diverticulitis. * recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: * biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. * other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: 1. glucocorticoids in high doses (\> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; 2. jak inhibitors; etc. * concurrent participation in another clinical trial during 30 days before screening. * pregnancy or lactation. * a history of active tuberculosis, or active tuberculosis suspected by the investigator. * administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study * patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.

* presence of any of the following laboratory abnormalities: absolute neutrophil counts \<0,5 х 10\^9/l white blood cell count \< 2 х 10\^9/l, platelet count \< 50 х 10\^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) * kidney injury with creatinine clearance \<30 ml/min. * hypersensitivity to okz, and/or its components. * septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). * estimated survival of less than 24 hours regardless of treatment. * history of perforation of the gastrointestinal tract, history of diverticulitis. * recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: * biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. * other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: 1. glucocorticoids in high doses (\> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; 2. jak inhibitors; etc. * concurrent participation in another clinical trial during 30 days before screening. * pregnancy or lactation. * a history of active tuberculosis, or active tuberculosis suspected by the investigator. * administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study * patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.

Nov. 16, 2021, 6:30 p.m. usa

presence of any of the following laboratory abnormalities: absolute neutrophil counts <0,5 х 10^9/l white blood cell count < 2 х 10^9/l, platelet count < 50 х 10^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) kidney injury with creatinine clearance <30 ml/min. hypersensitivity to okz, and/or its components. septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). estimated survival of less than 24 hours regardless of treatment. history of perforation of the gastrointestinal tract, history of diverticulitis. recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: glucocorticoids in high doses (> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; jak inhibitors; etc. concurrent participation in another clinical trial during 30 days before screening. pregnancy or lactation. a history of active tuberculosis, or active tuberculosis suspected by the investigator. administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.

presence of any of the following laboratory abnormalities: absolute neutrophil counts <0,5 х 10^9/l white blood cell count < 2 х 10^9/l, platelet count < 50 х 10^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) kidney injury with creatinine clearance <30 ml/min. hypersensitivity to okz, and/or its components. septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). estimated survival of less than 24 hours regardless of treatment. history of perforation of the gastrointestinal tract, history of diverticulitis. recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: glucocorticoids in high doses (> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; jak inhibitors; etc. concurrent participation in another clinical trial during 30 days before screening. pregnancy or lactation. a history of active tuberculosis, or active tuberculosis suspected by the investigator. administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.

Oct. 26, 2020, 11:31 p.m. usa

- presence of any of the following laboratory abnormalities: absolute neutrophil counts <0,5 х 10^9/l white blood cell count < 2 х 10^9/l, platelet count < 50 х 10^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) - kidney injury with creatinine clearance <30 ml/min. - hypersensitivity to okz, and/or its components. - septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). - estimated survival of less than 24 hours regardless of treatment. - history of perforation of the gastrointestinal tract, history of diverticulitis. - recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: - biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. - other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: 1. glucocorticoids in high doses (> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; 2. jak inhibitors; etc. - concurrent participation in another clinical trial during 30 days before screening. - pregnancy or lactation. - a history of active tuberculosis, or active tuberculosis suspected by the investigator. - administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study - patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.

- presence of any of the following laboratory abnormalities: absolute neutrophil counts <0,5 х 10^9/l white blood cell count < 2 х 10^9/l, platelet count < 50 х 10^9/l, alanine aminotransferase (аlt) and/or aspartate aminotransferase (ast) ≥3,0 х upper limit of normal (uln) - kidney injury with creatinine clearance <30 ml/min. - hypersensitivity to okz, and/or its components. - septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥2 mmol / l in the absence of hypovolemia). - estimated survival of less than 24 hours regardless of treatment. - history of perforation of the gastrointestinal tract, history of diverticulitis. - recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs: - biologics (except okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), il-17a inhibitors (seсukinumab, etc.), tumor necrosis factor-alpha (tnf-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-b-cells therapy, etc.;. - other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to: 1. glucocorticoids in high doses (> 1 mg / kg equivalent of methylprednisolone) orally and parenterally; 2. jak inhibitors; etc. - concurrent participation in another clinical trial during 30 days before screening. - pregnancy or lactation. - a history of active tuberculosis, or active tuberculosis suspected by the investigator. - administration of plasma from covid-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study - patients who deteriorated into category 4 of the 5-point clinical status scale within more than the last 24 hours.