COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000736-37/DE

Biotest AG - Clinical Trial Information

clinical.trials@biotest.com

2022-05-31

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Written informed consent obtained from the subject or legally acceptable/authorized representative (LAR) in compliance with all local legal requirements. 2. Hospitalized, adult (≥ 18 years of age) subject (any gender). 3. Diagnosis of CAP (e.g., according to ATS/IDSA guideline) or COVID- 19 pneumonia (e.g., according to local guidelines) before or within 48 hours after hospital admission, and with radiologic evidence (available from routine SoC done before or after hospital admission) showing new pulmonary lobar or multilobar infiltrates consistent with CAP or COVID-19 pneumonia. 4. Receiving oxygen supply via low-flow oxygen (LFO, by mask or nasal prongs with > 2 L/min) or on non-invasive ventilation (NIV) or high-flow oxygen (HFO) at start of treatment with investigational medicinal product (IMP). 5. Fulfilling at least one of the following clinical respiratory parameters within 24 hours prior to start of treatment with IMP: SpO2 ≤ 94% (on room air, and without preceding chronic lung disease), 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg under HFO or NIV. 6. C-reactive protein (CRP) ≥ 50 mg/L within 24 hours prior to start of treatment with IMP. 7. D-dimer ≤ 3 mg/L and platelets ≥ 130 x10^9/L within 24 hours prior to start of treatment with IMP. 8. Treatment with IMP has to be started within 7 days after first hospital-admission for CAP or COVID-19 pneumonia. 9. Subject must receive SoC treatment for CAP or COVID-19 pneumonia

1. Pregnant or lactating women. 2. Subjects of child bearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. 3. Subject on invasive mechanical ventilation (IMV) and/or extracorporeal membrane oxygenation (ECMO) or predicted to be on IMV and/or ECMO at start of IMP treatment. 4. Subject with septic shock and in need for vasopressors at start of IMP treatment. 5. Subject with sustained improvement in any form of oxygen supply (e.g., change from IMV to NIV/HFO/LFO, or change from HFO to LFO) during the last 7 days or with predicted cessation of oxygen supply at start of treatment. 6. Severe neutropenia (neutrophil count < 0.5 x10^9/L) assessed within 24 hours prior to start of treatment. 7. Hemoglobin < 7g/dL assessed within 24 hours prior to start of treatment. 8. Pre-existing hemolytic disease. 9. Pre-existing thrombosis or thromboembolic events (TEEs) (e.g., cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within 3 months before entering the trial. Subjects particularly at risk for TEEs caused by other reasons than the current pneumonia (e.g., history of thrombophilia, permanent immobilization, or permanent paralysis of lower extremities). 10. Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² assessed within 24 hours prior to start of treatment. 11. Subject with end stage renal disease (ESRD), or primary focal segmental glomerulosclerosis (FSGS). 12. Pre-existing severe lung diseases concomitant to current pneumonia (e.g., COPD (GOLD stage III-IV / Group D), severe interstitial lung disease [including idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, aspiration pneumonia or active lung cancer). 13. Pre-existing decompensated heart failure (New York Heart Association class III–IV). 14. Pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 points), or hepatocellular carcinoma. 15. Known intolerance to proteins of human origin or known allergic reactions to any of the components of trimodulin / placebo. 16. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA. 17. Known human immunodeficiency virus infection. 18. Life expectancy of less than 90 days, according to the Investigator’s clinical judgment, because of medical conditions related neither to current pneumonia, nor to associated medical complications. 19. Morbid obesity with high body mass index ≥ 40 kg/m², or malnutrition with low body mass index < 16 kg/m². 20. Treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before entering the trial. 21. Ongoing treatment with selective immune modulators (targeted and anti-inflammatory drugs) like cytokine inhibitors, receptor inhibitors, kinase inhibitors (Exceptions: corticosteroids, non-steroidal anti-inflammatory drugs [NSAIDs] and previous use of COVID-19 guideline-recommended immune modulating drugs if for treatment of COVID-19). 22. Treatment with fluoroquinolone preparations during the last 5 days before entering the trial. 23. Treatment with any type of interferon during the last 21 days before entering the trial. 24. Ongoing treatment with immunosuppressants like anti-proliferative/anti-cancer drugs, drugs used in transplantation or autoimmune diseases (Exception: corticosteroids). 25. Participation in another interventional clinical trial (using medications and/or procedures not according to SoC of the trial site) within 30 days before screening, or previous participation in this clinical trial. 26. Employee or direct relative of an employee of the contract research organization, the trial site, or Biotest. 27. Persons, subject to legal protection measures, if applicable according to local laws.

2

Biotest AG

18

100

Argentina;Brazil;South Africa;Austria;Belgium;France;Germany;Hungary;Latvia;Lithuania;Portugal;Slovakia;Spain;Türkiye

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

29

Composite primary endpoint: Deterioration / mortality rate

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

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