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

* subjects currently receiving invasive mechanical ventilation * presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) * evidence of serious active infection other than covid-19 * current diagnosis of human immunodeficiency virus, hepatitis b or c * in the opinion of the investigator, unlikely to survive for \> 24 hours from enrollment * women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication * presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt \>3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) \< 50ml/min) or receiving renal replacement therapy * presence of septic shock at time of enrollment * hemoglobin \< 80 g/l * evidence of neutropenia (i.e., absolute neutrophil count \< 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count \< 200 cells/ul) or thrombocytopenia (i.e.platelets \< 50×10\^9/l) * hypersensitivity to td-0903 or its components, or to other jak inhibitors * treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period * current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: 1. methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment 2. azathioprine or cyclophosphamide within 12 weeks prior to enrollment 3. monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment 4. tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment * participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol * subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months * subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days * body mass index ≥40 kg/m2 * receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects * history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)

* subjects currently receiving invasive mechanical ventilation * presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) * evidence of serious active infection other than covid-19 * current diagnosis of human immunodeficiency virus, hepatitis b or c * in the opinion of the investigator, unlikely to survive for \> 24 hours from enrollment * women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication * presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt \>3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) \< 50ml/min) or receiving renal replacement therapy * presence of septic shock at time of enrollment * hemoglobin \< 80 g/l * evidence of neutropenia (i.e., absolute neutrophil count \< 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count \< 200 cells/ul) or thrombocytopenia (i.e.platelets \< 50×10\^9/l) * hypersensitivity to td-0903 or its components, or to other jak inhibitors * treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period * current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: 1. methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment 2. azathioprine or cyclophosphamide within 12 weeks prior to enrollment 3. monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment 4. tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment * participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol * subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months * subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days * body mass index ≥40 kg/m2 * receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects * history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)

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

subjects currently receiving invasive mechanical ventilation presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) evidence of serious active infection other than covid-19 current diagnosis of human immunodeficiency virus, hepatitis b or c in the opinion of the investigator, unlikely to survive for > 24 hours from enrollment women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt >3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) < 50ml/min) or receiving renal replacement therapy presence of septic shock at time of enrollment hemoglobin < 80 g/l evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count < 200 cells/ul) or thrombocytopenia (i.e.platelets < 50×10^9/l) hypersensitivity to td-0903 or its components, or to other jak inhibitors treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment azathioprine or cyclophosphamide within 12 weeks prior to enrollment monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days body mass index ≥40 kg/m2 receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)

subjects currently receiving invasive mechanical ventilation presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) evidence of serious active infection other than covid-19 current diagnosis of human immunodeficiency virus, hepatitis b or c in the opinion of the investigator, unlikely to survive for > 24 hours from enrollment women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt >3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) < 50ml/min) or receiving renal replacement therapy presence of septic shock at time of enrollment hemoglobin < 80 g/l evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count < 200 cells/ul) or thrombocytopenia (i.e.platelets < 50×10^9/l) hypersensitivity to td-0903 or its components, or to other jak inhibitors treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment azathioprine or cyclophosphamide within 12 weeks prior to enrollment monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days body mass index ≥40 kg/m2 receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)

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

- subjects currently receiving invasive mechanical ventilation - presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) - evidence of serious active infection other than covid-19 - current diagnosis of human immunodeficiency virus, hepatitis b or c - in the opinion of the investigator, unlikely to survive for > 24 hours from enrollment - women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication - presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt >3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) < 50ml/min) or receiving renal replacement therapy - presence of septic shock at time of enrollment - hemoglobin < 80 g/l - evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count < 200 cells/ul) or thrombocytopenia (i.e.platelets < 50×10^9/l) - hypersensitivity to td-0903 or its components, or to other jak inhibitors - treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period - current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: 1. methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment 2. azathioprine or cyclophosphamide within 12 weeks prior to enrollment 3. monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment 4. tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment - participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol - subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months - subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days - body mass index ≥40 kg/m2 - receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects - history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)

- subjects currently receiving invasive mechanical ventilation - presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer) - evidence of serious active infection other than covid-19 - current diagnosis of human immunodeficiency virus, hepatitis b or c - in the opinion of the investigator, unlikely to survive for > 24 hours from enrollment - women who are pregnant or might be pregnant, or who are currently breast-feeding. subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication - presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. such conditions might include: a. new york heart association class iv heart failure b. hepatic dysfunction (i.e., ast or alt >3x upper limit of normal) c. renal dysfunction (i.e., estimated glomerular filtration rate (egfr) < 50ml/min) or receiving renal replacement therapy - presence of septic shock at time of enrollment - hemoglobin < 80 g/l - evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/ul), lymphopenia (i.e., absolute lymphocyte count < 200 cells/ul) or thrombocytopenia (i.e.platelets < 50×10^9/l) - hypersensitivity to td-0903 or its components, or to other jak inhibitors - treatment with anti-il 6 (e.g., tocilizumab, sarilumab), anti-il-6r antagonists (e.g., abatacept), jak inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a jak inhibitor during the study period - current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (dmards)/immunosuppressive agents including: 1. methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment 2. azathioprine or cyclophosphamide within 12 weeks prior to enrollment 3. monoclonal antibodies targeting b cells (e.g., rituximab) within 12 weeks prior to enrollment 4. tumor necrosis factor-alpha (tnfα)) inhibitors within 4 weeks prior to enrollment - participating in other clinical trials involving any other experimental treatment for covid-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol - subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months - subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days - body mass index ≥40 kg/m2 - receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. note: use of non-live (inactivated) vaccinations is allowed for all subjects - history of venous thromboembolism (vte), deep venous thrombosis (dvt), pulmonary embolism (pe) or known hypercoagulable disorder (e.g., factor v leiden, antiphospholipid antibody syndrome, protein c or s deficiency)