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

1. patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. 2. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). 3. anti-rejection or immunomodulatory drugs within the past 3 months. 4. absolute neutrophil count (anc) \< 1000/µl at screening. 5. platelet count \< 50,000/ µl at screening. 6. alt or ast \> 5 x upper limit of normal (uln) within 24 hours at screening. 7. serum creatinine \> 2 mg/dl (\> 176.8 μmol/l) or estimated creatinine clearance \< 30 ml/min measured or calculated by cockroft gault equation. 8. pregnancy or breastfeeding. 9. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). 10. patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome \[ards\], septicaemia).

1. patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. 2. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). 3. anti-rejection or immunomodulatory drugs within the past 3 months. 4. absolute neutrophil count (anc) \< 1000/µl at screening. 5. platelet count \< 50,000/ µl at screening. 6. alt or ast \> 5 x upper limit of normal (uln) within 24 hours at screening. 7. serum creatinine \> 2 mg/dl (\> 176.8 μmol/l) or estimated creatinine clearance \< 30 ml/min measured or calculated by cockroft gault equation. 8. pregnancy or breastfeeding. 9. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). 10. patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome \[ards\], septicaemia).

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

patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). anti-rejection or immunomodulatory drugs within the past 3 months. absolute neutrophil count (anc) < 1000/µl at screening. platelet count < 50,000/ µl at screening. alt or ast > 5 x upper limit of normal (uln) within 24 hours at screening. serum creatinine > 2 mg/dl (> 176.8 μmol/l) or estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation. pregnancy or breastfeeding. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ards], septicaemia).

patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). anti-rejection or immunomodulatory drugs within the past 3 months. absolute neutrophil count (anc) < 1000/µl at screening. platelet count < 50,000/ µl at screening. alt or ast > 5 x upper limit of normal (uln) within 24 hours at screening. serum creatinine > 2 mg/dl (> 176.8 μmol/l) or estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation. pregnancy or breastfeeding. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ards], septicaemia).

Dec. 23, 2020, 12:31 a.m. usa

1. patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. 2. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). 3. anti-rejection or immunomodulatory drugs within the past 3 months. 4. absolute neutrophil count (anc) < 1000/µl at screening. 5. platelet count < 50,000/ µl at screening. 6. alt or ast > 5 x upper limit of normal (uln) within 24 hours at screening. 7. serum creatinine > 2 mg/dl (> 176.8 μmol/l) or estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation. 8. pregnancy or breastfeeding. 9. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). 10. patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ards], septicaemia).

1. patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. 2. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). 3. anti-rejection or immunomodulatory drugs within the past 3 months. 4. absolute neutrophil count (anc) < 1000/µl at screening. 5. platelet count < 50,000/ µl at screening. 6. alt or ast > 5 x upper limit of normal (uln) within 24 hours at screening. 7. serum creatinine > 2 mg/dl (> 176.8 μmol/l) or estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation. 8. pregnancy or breastfeeding. 9. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). 10. patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ards], septicaemia).