Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

patients who are unable to follow clinical and follow-up procedures patients with symptoms of moderate or higher in the severity classification presented by fda have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc) patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months patients who have uncontrolled type ii diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dl) if the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmhg), and active bleeding tendency patients who are known to be hiv positive patients who are known to be b-type, or c-type hepatitis-positive carrier patients who are pregnant or breastfeeding patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the ip administration patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present patients who have previously received an allogeneic marrow transplantation or solid organ transplantation patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity patients who have received other ip administration while participating in another clinical trial within 30 days prior to the ip administration for this study (however, biological preparation shall be applied to 60 days and even longer period can be applied considering the half-life) -

patients who are unable to follow clinical and follow-up procedures patients with symptoms of moderate or higher in the severity classification presented by fda have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc) patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months patients who have uncontrolled type ii diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dl) if the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmhg), and active bleeding tendency patients who are known to be hiv positive patients who are known to be b-type, or c-type hepatitis-positive carrier patients who are pregnant or breastfeeding patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the ip administration patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present patients who have previously received an allogeneic marrow transplantation or solid organ transplantation patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity patients who have received other ip administration while participating in another clinical trial within 30 days prior to the ip administration for this study (however, biological preparation shall be applied to 60 days and even longer period can be applied considering the half-life) -

March 25, 2021, 12:31 a.m. usa

1. patients who are unable to follow clinical and follow-up procedures 2. patients with symptoms of moderate or higher in the severity classification presented by fda have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc) 3. patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months 4. patients who have uncontrolled type ii diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dl) 5. if the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmhg), and active bleeding tendency 6. patients who are known to be hiv positive 7. patients who are known to be b-type, or c-type hepatitis-positive carrier 8. patients who are pregnant or breastfeeding 9. patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years 10. patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the ip administration 11. patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present 12. patients who have previously received an allogeneic marrow transplantation or solid organ transplantation 13. patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study 14. patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity 15. patients who have received other ip administration while participating in another clinical trial within 30 days prior to the ip administration for this study (however, biological preparation shall be applied to 60 days and even longer period can be applied considering the half-life) -

1. patients who are unable to follow clinical and follow-up procedures 2. patients with symptoms of moderate or higher in the severity classification presented by fda have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc) 3. patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months 4. patients who have uncontrolled type ii diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dl) 5. if the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmhg), and active bleeding tendency 6. patients who are known to be hiv positive 7. patients who are known to be b-type, or c-type hepatitis-positive carrier 8. patients who are pregnant or breastfeeding 9. patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years 10. patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the ip administration 11. patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present 12. patients who have previously received an allogeneic marrow transplantation or solid organ transplantation 13. patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study 14. patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity 15. patients who have received other ip administration while participating in another clinical trial within 30 days prior to the ip administration for this study (however, biological preparation shall be applied to 60 days and even longer period can be applied considering the half-life) -