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 or predicted to be 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 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. Pre-existing hemolytic disease.

11. Pre-existing thrombosis or other thromboembolic events (TEEs) within 3 months beforestart of IMP treatment. Subjects particularly at risk for TEEs caused by otherreasons than the current sCAP.

12. Subject on dialysis or with severe renal impairment within 24 hours prior to startof IMP treatment.

13. Subject with end-stage renal disease (ESRD) or known primary focal segmentalglomerulosclerosis (FSGS).

14. Pre-existing severe lung diseases concomitant to current sCAP (e.g., subjects withchronic obstructive pulmonary disease [COPD] Gold Stage III or IV, severeinterstitial lung disease [incl. idiopathic pulmonary fibrosis], cystic fibrosis,active tuberculosis, chronically infected bronchiectasis, or 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. Treatment with any type of interferon during the last 21 days before start of IMPtreatment

24. Subject with previous organ or hematopoietic stem cell transplantation receivingongoing treatment with immunosuppressants (exception: corticosteroids) at start ofIMP treatment.

25. Participation in another interventional clinical trial (using medications and/orprocedures not according to SoC of the trial site) within 30 days before start ofIMP treatment or previous IMP treatment in this clinical trial.