Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock

Exclusion Criteria

• •1. Previous episode of septic shock requiring vasopressor administration within current hospital stay
• •2. Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids \>75 mg prednisone daily or equivalent for more than 7 days
• •3. Immunosuppressive therapy related to recent (\<6 months) transplantation
• •4. Cancer chemotherapy (\<3 months) implying an immunodepression
• •5. Known HIV infection with low CD4 cell count (\<200) for at least 6 months
• •6. Known pregnancy (positive urine or serum pregnancy test)
• •7. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
• •8. Ongoing documented or suspected endocarditis, history of prosthetic heart valves
• •9. Prolonged QT syndrome
• •10. End-stage neurological disease
• •11. End-stage cirrhosis (Child Pugh Class C)
• •12. Acute Physiology and Chronic Health Evaluation (APACHE II) score \<15 or ≥ 34
• •13. Home oxygen therapy on a regular basis for \> 6 h/day
• •14. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
• •15. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
• •16. Moribund patients
• •17. Decision to limit full care taken before obtaining informed consent
• •18. Participation in another interventional study in the 3 months prior to randomization