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

Main Inclusion Criteria:

1. Written informed consent.

2. Hospitalized, adult (≥ 18 years of age) subject.

3. Signs of inflammation based on C-reactive protein threshold level.

4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission orwithin 48 hours after admission.

5. Radiological (or other imaging technology) evidence consistent with activepneumonia.

6. Acute respiratory failure requiring IMV.

Main Exclusion Criteria:

1. For an incapacitated subject: any indication that the subject's presumed will wouldbe against inclusion in the trial.

2. Pregnant or lactating women.

3. Subjects of childbearing potential not willing to use reliable contraceptivemeasures during the trial and for 15 weeks after the last IMP treatment.

4. Subjects on ECMO at start of IMP treatment.

5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associatedpneumonia (VAP).

6. Subjects discharged from hospital within the previous 14 days.

7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment.

8. Defined platelet counts up to one calendar day prior to start of IMP treatment.

9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment.

10. Pre-existing hemolytic disease.

11. Thromboembolic events (TEEs) caused by other reasons than the current sCAP within 3months before start of IMP treatment unless the risk for further TEEs can beadequately managed with standard prophylaxis or treatment.

12. Severe renal impairment prior to start of IMP treatment.

13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).

14. Pre-existing severe lung diseases concomitant to current sCAP (e.g. activetuberculosis, active lung cancer).

15. Pre-existing decompensated heart failure.

16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severehepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.

17. Known intolerance to proteins of human origin or known allergic reactions tocomponents of trimodulin / placebo.

18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.

19. Life expectancy of less than 90 days, according to the investigator's clinicaljudgment, because of medical conditions related neither to sCAP nor tosCAP-associated septic conditions.

20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with lowBMI < 16 kg/m2.

21. Treatment with polyvalent immunoglobulin preparations during the last 21 days beforestart of IMP treatment.

22. Known treatment with predefined medications, during the last 2 days before start ofIMP treatment.

23. Hematopoietic stem cell transplantation or previous lung transplantation.

24. Treatment with investigational medications/procedures not according to SoC of thetrial site, due to participation in another interventional clinical trial within 30days before start of IMP treatment, or previous treatment with IMP in this clinicaltrial.