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

1. individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) 2. individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic \<90mmhg or diastolic \<60mmhg, or in case need a blood pressure booster) - multiple organ failure 3. patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) 4. patients with severe heart failure (nyha class iii or higher) 5. pregnant women 6. men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. 7. those who are scheduled to have organ transplantation 8. those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr \< 30 ml/min/1.73m2 ③ platelets \< 50,000/mm3 9. those who have a positive result for serology (hepatitis b, human immunodeficiency virus \[hiv\], and hepatitis c tests) at screening 10. those who administered other investigational products within 30 days prior to the screening visit 11. others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

1. individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) 2. individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic \<90mmhg or diastolic \<60mmhg, or in case need a blood pressure booster) - multiple organ failure 3. patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) 4. patients with severe heart failure (nyha class iii or higher) 5. pregnant women 6. men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. 7. those who are scheduled to have organ transplantation 8. those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr \< 30 ml/min/1.73m2 ③ platelets \< 50,000/mm3 9. those who have a positive result for serology (hepatitis b, human immunodeficiency virus \[hiv\], and hepatitis c tests) at screening 10. those who administered other investigational products within 30 days prior to the screening visit 11. others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

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

individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic <90mmhg or diastolic <60mmhg, or in case need a blood pressure booster) - multiple organ failure patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) patients with severe heart failure (nyha class iii or higher) pregnant women men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. those who are scheduled to have organ transplantation those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr < 30 ml/min/1.73m2 ③ platelets < 50,000/mm3 those who have a positive result for serology (hepatitis b, human immunodeficiency virus [hiv], and hepatitis c tests) at screening those who administered other investigational products within 30 days prior to the screening visit others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic <90mmhg or diastolic <60mmhg, or in case need a blood pressure booster) - multiple organ failure patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) patients with severe heart failure (nyha class iii or higher) pregnant women men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. those who are scheduled to have organ transplantation those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr < 30 ml/min/1.73m2 ③ platelets < 50,000/mm3 those who have a positive result for serology (hepatitis b, human immunodeficiency virus [hiv], and hepatitis c tests) at screening those who administered other investigational products within 30 days prior to the screening visit others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Dec. 24, 2020, 12:31 a.m. usa

1. individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) 2. individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic <90mmhg or diastolic <60mmhg, or in case need a blood pressure booster) - multiple organ failure 3. patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) 4. patients with severe heart failure (nyha class iii or higher) 5. pregnant women 6. men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. 7. those who are scheduled to have organ transplantation 8. those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr < 30 ml/min/1.73m2 ③ platelets < 50,000/mm3 9. those who have a positive result for serology (hepatitis b, human immunodeficiency virus [hiv], and hepatitis c tests) at screening 10. those who administered other investigational products within 30 days prior to the screening visit 11. others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

1. individuals with a clinically significant history of hypersensitivity reactions to the components of hzvsf-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.) 2. individuals with a severe at screening - breathing disorder that requires treatment of one or more of the following: oxygen therapy using high-flow nasal cannula (hfnc), noninvasive positive pressure ventilation (niv), invasive mechanical ventilation, ecmo, clinical diagnosis of respiratory failure - shock (systolic <90mmhg or diastolic <60mmhg, or in case need a blood pressure booster) - multiple organ failure 3. patients with pneumonia other than due to the novel coronavirus (sars-cov-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia) 4. patients with severe heart failure (nyha class iii or higher) 5. pregnant women 6. men or women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration ① surgical infertility (e.g., bilateral tubal ligation, vasectomy) ② hormonal contraceptives (hormone releasing iud, implantable form, patch, oral hormone) ③ double-barrier method (concomitant use of two of the following: iud, male or female condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide) periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods, and effective contraceptive methods must be kept being used during the course of the clinical study. 7. those who are scheduled to have organ transplantation 8. those who have laboratory test results that fall under the following values at screening ① alt or ast ≥5 times the upper limit of normal (uln) ② egfr < 30 ml/min/1.73m2 ③ platelets < 50,000/mm3 9. those who have a positive result for serology (hepatitis b, human immunodeficiency virus [hiv], and hepatitis c tests) at screening 10. those who administered other investigational products within 30 days prior to the screening visit 11. others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion