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

1. a history of hypersensitivity to the study drugs (rph-104 and/or okz), and/or their components. 2. the presence of any of the following laboratory abnormalities: * absolute neutrophil counts \< 0.5 x 10\^9 l * white blood cell count \< 2 x 10\^9 l * platelet count \<50 x 10\^9 l * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) 3. severe renal failure: creatinine clearance \< 30 ml/min 4. septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia) 5. the disease progresses to death over the next 24 hours, regardless of treatment, according to investigator. 6. perforation of the gastrointestinal tract, a history of diverticulitis. 7. administration of plasma from covid-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study. 8. recent (less then 5 half-lives) administration of tocilizumab or sarilumab; 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: * biologics (except rph-104 or okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il- 6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab), tumor necrosis factor α (tnfα) inhibitors (infliximab, adalimumab, etanercept, etc.), antib-cell drugs, etc. * other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to: 1. high doses of glucocorticoids (equivalent to prednisolone \> 1 mg/kg) orally or parenterally; 2. janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. 10. concurrent participation in another clinical trial. 11. pregnancy, breastfeeding. 12. a history of active tuberculosis, or active tuberculosis suspected by the investigator.

1. a history of hypersensitivity to the study drugs (rph-104 and/or okz), and/or their components. 2. the presence of any of the following laboratory abnormalities: * absolute neutrophil counts \< 0.5 x 10\^9 l * white blood cell count \< 2 x 10\^9 l * platelet count \<50 x 10\^9 l * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) 3. severe renal failure: creatinine clearance \< 30 ml/min 4. septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia) 5. the disease progresses to death over the next 24 hours, regardless of treatment, according to investigator. 6. perforation of the gastrointestinal tract, a history of diverticulitis. 7. administration of plasma from covid-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study. 8. recent (less then 5 half-lives) administration of tocilizumab or sarilumab; 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: * biologics (except rph-104 or okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il- 6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab), tumor necrosis factor α (tnfα) inhibitors (infliximab, adalimumab, etanercept, etc.), antib-cell drugs, etc. * other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to: 1. high doses of glucocorticoids (equivalent to prednisolone \> 1 mg/kg) orally or parenterally; 2. janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. 10. concurrent participation in another clinical trial. 11. pregnancy, breastfeeding. 12. a history of active tuberculosis, or active tuberculosis suspected by the investigator.

Jan. 26, 2022, 10:48 a.m. usa

a history of hypersensitivity to the study drugs (rph-104 and/or okz), and/or their components. the presence of any of the following laboratory abnormalities: absolute neutrophil counts < 0.5 x 10^9 l white blood cell count < 2 x 10^9 l platelet count <50 x 10^9 l alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) severe renal failure: creatinine clearance < 30 ml/min septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia) the disease progresses to death over the next 24 hours, regardless of treatment, according to investigator. perforation of the gastrointestinal tract, a history of diverticulitis. administration of plasma from covid-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study. recent (less then 5 half-lives) administration of tocilizumab or sarilumab; recent (less then 5 half-lives) or planned during the current study period use of the following drugs: biologics (except rph-104 or okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il- 6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab), tumor necrosis factor α (tnfα) inhibitors (infliximab, adalimumab, etanercept, etc.), antib-cell drugs, etc. other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to: high doses of glucocorticoids (equivalent to prednisolone > 1 mg/kg) orally or parenterally; janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. concurrent participation in another clinical trial. pregnancy, breastfeeding. a history of active tuberculosis, or active tuberculosis suspected by the investigator.

a history of hypersensitivity to the study drugs (rph-104 and/or okz), and/or their components. the presence of any of the following laboratory abnormalities: absolute neutrophil counts < 0.5 x 10^9 l white blood cell count < 2 x 10^9 l platelet count <50 x 10^9 l alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) severe renal failure: creatinine clearance < 30 ml/min septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia) the disease progresses to death over the next 24 hours, regardless of treatment, according to investigator. perforation of the gastrointestinal tract, a history of diverticulitis. administration of plasma from covid-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study. recent (less then 5 half-lives) administration of tocilizumab or sarilumab; recent (less then 5 half-lives) or planned during the current study period use of the following drugs: biologics (except rph-104 or okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il- 6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab), tumor necrosis factor α (tnfα) inhibitors (infliximab, adalimumab, etanercept, etc.), antib-cell drugs, etc. other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to: high doses of glucocorticoids (equivalent to prednisolone > 1 mg/kg) orally or parenterally; janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. concurrent participation in another clinical trial. pregnancy, breastfeeding. a history of active tuberculosis, or active tuberculosis suspected by the investigator.

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

1. hypersensitivity to the study drugs (rph-104 and/or okz), and/or its components. 2. presence of any of the following laboratory abnormalities: absolute neutrophil counts < 0.5 x 10^9 l white blood cell count < 2 x 10^9 l platelet count <50 x 10^9 l alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) 3. severe renal failure: creatinine clearance < 30 ml/min 4. septic shock (to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia, vasopressors are necessary) 5. progression of disease up to the death in the following 24 hours regardless of treatment, as per investigator's opinion 6. history of perforation of gastrointestinal tract, history of diverticulitis 7. plasma infusion from convalescent covid-19 donors within 4 weeks prior to patient inclusion and/or planned infusion during the study 8.recent (less then 5 half-lives) administration of tocilizumab or sarilumab; 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: immunosuppressive biologics over than okz or rph-104, including but not limited, interleukin-1 (il-1) inhibitors (rilonacept, anakinra, canakinumab) , il-6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab),tumor necrosis factor α (tnfα) inhibitors (adalimumab, infliximab, etanercept), anti-b-cell therapy and others other immunosuppressors except methotrexate dosed up to 25 mg per week, including but not limited: high-dose glucocorticoids ( > 1mg/kg of prednisolone equivalent), oral and parental; jak inhibitors, cyclophosphamide, and others 10. concurrent participation in another clinical trial. 11. pregnancy or lactation 12. history of active tuberculosis, active tuberculosis suspected by investigator

1. hypersensitivity to the study drugs (rph-104 and/or okz), and/or its components. 2. presence of any of the following laboratory abnormalities: absolute neutrophil counts < 0.5 x 10^9 l white blood cell count < 2 x 10^9 l platelet count <50 x 10^9 l alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) 3. severe renal failure: creatinine clearance < 30 ml/min 4. septic shock (to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia, vasopressors are necessary) 5. progression of disease up to the death in the following 24 hours regardless of treatment, as per investigator's opinion 6. history of perforation of gastrointestinal tract, history of diverticulitis 7. plasma infusion from convalescent covid-19 donors within 4 weeks prior to patient inclusion and/or planned infusion during the study 8.recent (less then 5 half-lives) administration of tocilizumab or sarilumab; 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: immunosuppressive biologics over than okz or rph-104, including but not limited, interleukin-1 (il-1) inhibitors (rilonacept, anakinra, canakinumab) , il-6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab),tumor necrosis factor α (tnfα) inhibitors (adalimumab, infliximab, etanercept), anti-b-cell therapy and others other immunosuppressors except methotrexate dosed up to 25 mg per week, including but not limited: high-dose glucocorticoids ( > 1mg/kg of prednisolone equivalent), oral and parental; jak inhibitors, cyclophosphamide, and others 10. concurrent participation in another clinical trial. 11. pregnancy or lactation 12. history of active tuberculosis, active tuberculosis suspected by investigator

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

- 1. hypersensitivity to the study drugs (rph-104 and/or okz), and/or its components. - 2. presence of any of the following laboratory abnormalities: - absolute neutrophil counts < 0.5 x 10^9 l - white blood cell count < 2 x 10^9 l - platelet count <50 x 10^9 l - alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) - 3. severe renal failure: creatinine clearance < 30 ml/min - 4. septic shock (to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia, vasopressors are necessary) - 5. progression of disease up to the death in the following 24 hours regardless of treatment, as per investigator's opinion - 6. history of perforation of gastrointestinal tract, history of diverticulitis - 7. plasma infusion from convalescent covid-19 donors within 4 weeks prior to patient inclusion and/or planned infusion during the study - 8.recent (less then 5 half-lives) administration of tocilizumab or sarilumab; - 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: - immunosuppressive biologics over than okz or rph-104, including but not limited, interleukin-1 (il-1) inhibitors (rilonacept, anakinra, canakinumab) , il-6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab),tumor necrosis factor α (tnfα) inhibitors (adalimumab, infliximab, etanercept), anti-b-cell therapy and others - other immunosuppressors except methotrexate dosed up to 25 mg per week, including but not limited: 1. high-dose glucocorticoids ( > 1mg/kg of prednisolone equivalent), oral and parental; 2. jak inhibitors, cyclophosphamide, and others - 10. concurrent participation in another clinical trial. - 11. pregnancy or lactation - 12. history of active tuberculosis, active tuberculosis suspected by investigator

- 1. hypersensitivity to the study drugs (rph-104 and/or okz), and/or its components. - 2. presence of any of the following laboratory abnormalities: - absolute neutrophil counts < 0.5 x 10^9 l - white blood cell count < 2 x 10^9 l - platelet count <50 x 10^9 l - alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) - 3. severe renal failure: creatinine clearance < 30 ml/min - 4. septic shock (to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia, vasopressors are necessary) - 5. progression of disease up to the death in the following 24 hours regardless of treatment, as per investigator's opinion - 6. history of perforation of gastrointestinal tract, history of diverticulitis - 7. plasma infusion from convalescent covid-19 donors within 4 weeks prior to patient inclusion and/or planned infusion during the study - 8.recent (less then 5 half-lives) administration of tocilizumab or sarilumab; - 9. recent (less then 5 half-lives) or planned during the current study period use of the following drugs: - immunosuppressive biologics over than okz or rph-104, including but not limited, interleukin-1 (il-1) inhibitors (rilonacept, anakinra, canakinumab) , il-6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab),tumor necrosis factor α (tnfα) inhibitors (adalimumab, infliximab, etanercept), anti-b-cell therapy and others - other immunosuppressors except methotrexate dosed up to 25 mg per week, including but not limited: 1. high-dose glucocorticoids ( > 1mg/kg of prednisolone equivalent), oral and parental; 2. jak inhibitors, cyclophosphamide, and others - 10. concurrent participation in another clinical trial. - 11. pregnancy or lactation - 12. history of active tuberculosis, active tuberculosis suspected by investigator