Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Details <br/ >Subjects who meet any of the following criteria cannot be enrolled in this trial <br/ > <br/ >Subjects already progressed into COVID19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. <br/ > <br/ >History of severe lung disease, such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis, history of severe heart disease, unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function â?¥grade 3 (NYHA Classification), history of severe liver disease (e.g. Child Pugh score â?¥grade C), history of severe kidney disease, such as renal insufficiency (GFR â?¤ 15ml/min/1.73m2), immune deficiencies or immune-related diseases: including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis, malignancies. <br/ > <br/ >Clear diagnosis of combining bacterial and fungal infections which would disturb the study resultsaccording to the opinion of the investigator. <br/ > <br/ >Subjects on current treatment with a complement inhibitor such as eculizumab. <br/ > <br/ >Subjects with a history of hypersensitivity to any ingredient contained in the study drug <br/ > <br/ >A subject has used the following drugs within 2 weeks (including 2 weeks) prior to screening procedures: <br/ > <br/ >Calcineurin inhibitors (e.g., ciclosporin, tacrolimus,etc.) <br/ >Immunosuppressant (e.g., everolimus, sirolimus,etc.) <br/ > <br/ >Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) <br/ > <br/ > <br/ >Pregnant or lactating women, Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: <br/ > <br/ >Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) <br/ > <br/ >Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) <br/ > <br/ >Intrauterine device <br/ > <br/ >Intrauterine hormone-releasing system <br/ > <br/ >Bilateral tubal occlusion <br/ > <br/ >Vasectomized partner <br/ > <br/ >Any other circumstances that the investigator considers inappropriate for the participation in this study

Details <br/ >Subjects who meet any of the following criteria cannot be enrolled in this trial <br/ > <br/ >Subjects already progressed into COVID19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. <br/ > <br/ >History of severe lung disease, such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis, history of severe heart disease, unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function â?¥grade 3 (NYHA Classification), history of severe liver disease (e.g. Child Pugh score â?¥grade C), history of severe kidney disease, such as renal insufficiency (GFR â?¤ 15ml/min/1.73m2), immune deficiencies or immune-related diseases: including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis, malignancies. <br/ > <br/ >Clear diagnosis of combining bacterial and fungal infections which would disturb the study resultsaccording to the opinion of the investigator. <br/ > <br/ >Subjects on current treatment with a complement inhibitor such as eculizumab. <br/ > <br/ >Subjects with a history of hypersensitivity to any ingredient contained in the study drug <br/ > <br/ >A subject has used the following drugs within 2 weeks (including 2 weeks) prior to screening procedures: <br/ > <br/ >Calcineurin inhibitors (e.g., ciclosporin, tacrolimus,etc.) <br/ >Immunosuppressant (e.g., everolimus, sirolimus,etc.) <br/ > <br/ >Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) <br/ > <br/ > <br/ >Pregnant or lactating women, Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: <br/ > <br/ >Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) <br/ > <br/ >Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) <br/ > <br/ >Intrauterine device <br/ > <br/ >Intrauterine hormone-releasing system <br/ > <br/ >Bilateral tubal occlusion <br/ > <br/ >Vasectomized partner <br/ > <br/ >Any other circumstances that the investigator considers inappropriate for the participation in this study

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Oct. 26, 2020, 8:29 a.m. oms

Details <br/ >Subjects who meet any of the following criteria cannot be enrolled in this trial <br/ > <br/ >Subjects already progressed into COVID19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. <br/ > <br/ >History of severe lung disease, such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis, history of severe heart disease, unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function â?¥grade 3 (NYHA Classification), history of severe liver disease (e.g. Child Pugh score â?¥grade C), history of severe kidney disease, such as renal insufficiency (GFR â?¤ 15ml/min/1.73m2), immune deficiencies or immune-related diseases: including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis, malignancies. <br/ > <br/ >Clear diagnosis of combining bacterial and fungal infections which would disturb the study resultsaccording to the opinion of the investigator. <br/ > <br/ >Subjects on current treatment with a complement inhibitor such as eculizumab. <br/ > <br/ >Subjects with a history of hypersensitivity to any ingredient contained in the study drug <br/ > <br/ >A subject has used the following drugs within 2 weeks (including 2 weeks) prior to screening procedures: <br/ > <br/ >Calcineurin inhibitors (e.g., ciclosporin, tacrolimus,etc.) <br/ >Immunosuppressant (e.g., everolimus, sirolimus,etc.) <br/ > <br/ >Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) <br/ > <br/ > <br/ >Pregnant or lactating women, Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: <br/ > <br/ >Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) <br/ > <br/ >Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) <br/ > <br/ >Intrauterine device <br/ > <br/ >Intrauterine hormone-releasing system <br/ > <br/ >Bilateral tubal occlusion <br/ > <br/ >Vasectomized partner <br/ > <br/ >Any other circumstances that the investigator considers inappropriate for the participation in this study

Details <br/ >Subjects who meet any of the following criteria cannot be enrolled in this trial <br/ > <br/ >Subjects already progressed into COVID19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. <br/ > <br/ >History of severe lung disease, such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis, history of severe heart disease, unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function â?¥grade 3 (NYHA Classification), history of severe liver disease (e.g. Child Pugh score â?¥grade C), history of severe kidney disease, such as renal insufficiency (GFR â?¤ 15ml/min/1.73m2), immune deficiencies or immune-related diseases: including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis, malignancies. <br/ > <br/ >Clear diagnosis of combining bacterial and fungal infections which would disturb the study resultsaccording to the opinion of the investigator. <br/ > <br/ >Subjects on current treatment with a complement inhibitor such as eculizumab. <br/ > <br/ >Subjects with a history of hypersensitivity to any ingredient contained in the study drug <br/ > <br/ >A subject has used the following drugs within 2 weeks (including 2 weeks) prior to screening procedures: <br/ > <br/ >Calcineurin inhibitors (e.g., ciclosporin, tacrolimus,etc.) <br/ >Immunosuppressant (e.g., everolimus, sirolimus,etc.) <br/ > <br/ >Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) <br/ > <br/ > <br/ >Pregnant or lactating women, Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: <br/ > <br/ >Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) <br/ > <br/ >Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) <br/ > <br/ >Intrauterine device <br/ > <br/ >Intrauterine hormone-releasing system <br/ > <br/ >Bilateral tubal occlusion <br/ > <br/ >Vasectomized partner <br/ > <br/ >Any other circumstances that the investigator considers inappropriate for the participation in this study