Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
- Conditions
- Community-acquired Pneumonia
- Registration Number
- NCT05722938
- Lead Sponsor
- Biotest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Main Inclusion Criteria:<br><br> 1. Written informed consent.<br><br> 2. Hospitalized, adult (= 18 years of age) subject.<br><br> 3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status.<br><br> 4. Signs of inflammation based on C-reactive protein threshold level.<br><br> 5. Diagnosis of active pneumonia.<br><br> 6. Radiological (or other imaging technology) evidence consistent with active<br> pneumonia.<br><br> 7. Acute respiratory failure requiring IMV.<br><br>Main Exclusion Criteria:<br><br> 1. For an incapacitated subject: any indication that the subject's presumed will would<br> be against inclusion in the trial.<br><br> 2. Pregnant or lactating women.<br><br> 3. Subjects not willing to use reliable contraceptive measures during the trial and for<br> 15 weeks after the last IMP treatment.<br><br> 4. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated<br> pneumonia (VAP).<br><br> 5. Diagnosis of COVID-19 during the last 4 weeks.<br><br> 6. Subjects that required oxygen therapy due to COVID-19 in the last 6 months.<br><br> 7. Defined neutrophil counts within 24 hours prior to start of IMP treatment.<br><br> 8. Defined platelet counts within 24 hours prior to start of IMP treatment.<br><br> 9. Defined hemoglobin within 24 hours prior to start of IMP treatment.<br><br> 10. Known hemolytic disease.<br><br> 11. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or<br> subjects particularly at risk for TEEs.<br><br> 12. Subject on dialysis or with severe renal impairment within 24 hours prior to start<br> of IMP treatment.<br><br> 13. Subject with end-stage renal disease (ESRD) or known primary focal segmental<br> glomerulosclerosis (FSGS).<br><br> 14. Known severe lung diseases interfering with sCAP therapy (e.g., subjects with<br> chronic obstructive pulmonary disease [COPD], severe interstitial lung disease<br> [incl. idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis,<br> chronically infected bronchiectasis, or active lung cancer).<br><br> 15. Known decompensated heart failure.<br><br> 16. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score =<br> 9 points), or hepatocellular carcinoma.<br><br> 17. Known intolerance to proteins of human origin or known allergic reactions to<br> components of trimodulin / placebo.<br><br> 18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.<br><br> 19. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months<br> before screening.<br><br> 20. Life expectancy of less than 90 days, according to the investigator's clinical<br> judgment, because of medical conditions related neither to sCAP nor to<br> sCAP-associated septic conditions.<br><br> 21. Morbid obesity with high body mass index (BMI) = 40 kg/m2, or malnutrition with low<br> BMI < 16 kg/m2.<br><br> 22. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin<br> preparations during the last 21 days before screening.<br><br> 23. Known treatment with predefined medications, during the last 5 days before<br> screening.<br><br> 24. Any type of interferon during the last 21 days before screening.<br><br> 25. Ongoing treatment with immunosuppressants other than guideline recommended<br> immunosuppressants for treatment of active pneumonia.<br><br> 26. Participation in another interventional clinical trial within 30 days before<br> screening or previous participation in this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28-day all-cause mortality rate
- Secondary Outcome Measures
Name Time Method