Efficacy and Safety of Trimodulin (BT588) in Subjects with Severe Community-acquired Pneumonia (sCAP)

Eligibility Criteria

• 1. Written informed consent.
• 2. Hospitalized, adult (≥ 18 years of age) subject.
• 3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status.
• 4. Signs of inflammation based on C-reactive protein threshold level.
• 5. Diagnosis of active pneumonia.
• 6. Radiological (or other imaging technology) evidence consistent with active pneumonia.
• 7. Acute respiratory failure requiring IMV.
• 1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
• 2. Pregnant or lactating women.
• 3. Subjects not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
• 4. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
• 5. Diagnosis of COVID-19 during the last 4 weeks.
• 6. Subjects that required oxygen therapy due to COVID-19 in the last 6 months.
• 7. Defined neutrophil counts within 24 hours prior to start of IMP treatment.
• 8. Defined platelet counts within 24 hours prior to start of IMP treatment.
• 9. Defined hemoglobin within 24 hours prior to start of IMP treatment.
• 10. Known hemolytic disease.
• 11. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs.
• 12. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment.
• 13. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
• 14. Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease \[COPD\], severe interstitial lung disease \[incl. idiopathic pulmonary fibrosis\], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).
• 15. Known decompensated heart failure.
• 16. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 points), or hepatocellular carcinoma.
• 17. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo.
• 18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.
• 19. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening.
• 20. Life expectancy of less than 90 days, according to the investigator's clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.
• 21. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2.
• 22. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening.
• 23. Known treatment with predefined medications, during the last 5 days before screening.
• 24. Any type of interferon during the last 21 days before screening.
• 25. Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia.
• 26. Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.