Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

Main Inclusion Criteria:

1. Written informed consent.

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

3. Diagnosis of CAP or COVID- 19 pneumonia (e.g. according to local guidelines) andwith radiologic evidence showing new pulmonary lobar or multilobar infiltratesconsistent with CAP or COVID-19 pneumonia.

4. Receiving oxygen supply via low-flow oxygen, high-flow oxygen or on non-invasiveventilation.

5. Fulfilling at least one clinical respiratory parameter (SpO2 ≤ 94% and/or 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg).

6. Signs of early systemic inflammation based on CRP and coagulation parameterthreshold levels.

Main Exclusion Criteria:

1. Pregnant or lactating women.

2. Subject on invasive mechanical ventilation and/or extracorporeal membraneoxygenation.

3. Subject with septic shock and in need for vasopressors.

4. Severe neutropenia prior to start of treatment.

5. Hemoglobin >7 g/dL prior to start of treatment.

6. Pre-existing hemolytic disease.

7. Pre-existing thromboembolic events (TEEs).

8. Subject on dialysis or with severe renal impairment prior to start of treatment.

9. Subject with end stage renal disease, or known primary focal segmentalglomerulosclerosis.

10. Pre-existing severe lung diseases to current pneumonia.

11. Pre-existing decompensated heart failure.

12. Pre-existing hepatic cirrhosis, severe hepatic impairment , or hepatocellularcarcinoma.

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

14. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.

15. Known human immunodeficiency virus infection.

16. Life expectancy of less than 90 days.

17. Morbid obesity or malnutrition.

18. Treatment with predefined medications (certain immune modulators orimmunosuppressants) before entering the trial.