COVID-19 trials registries data warehouse

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

Biotest AG - Clinical Trial Information

patrick.langohr@biotest.com

2022-09-01

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Written informed consent obtained from the subject or legally acceptable/authorized representative (LAR) or informed verbal consent in case of pandemic restrictions, in compliance with all local legal requirements. 2. Hospitalized, adult (≥ 18 years of age) subject (any gender). 3. Laboratory-confirmed acute SARS-CoV-2 infection within 5 days prior to screening. 4. Receiving oxygen supply via low-flow oxygen (LFO, by mask or nasal prongs) or on non-invasive ventilation (NIV) or high-flow oxygen (HFO) at start of treatment. 5. Fulfilling at least one of the following clinical respiratory parameters within 24 hours prior to start of treatment: - SpO2 ≤ 94% (on room air, and without preceding chronic lung disease), - 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg under HFO or NIV, - Radiologic evidence of COVID-19 pneumonia. 6. C-reactive protein ≥ 50 mg/L and ≤ 150 mg/L within 24 hours prior to start of treatment. 7. D-dimer ≤ 3 mg/L and platelets ≥ 130 x109/L within 24 hours prior to start of treatment. 8. Treatment with investigational medicinal product (IMP) has to be started within 7 days after first hospital-admission for COVID-19. 9. Subject must receive SoC treatment for COVID-19 according to Section 6.9 in the protocol.

1. Pregnant or lactating women. 2. Subject on invasive mechanical ventilation (IMV) and/or extracorporeal membrane oxygenation (ECMO) or predicted to be on IMV and/or ECMO at start of treatment. 3. 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. 4. Severe neutropenia (neutrophil count < 0.5 x109/L) assessed within 24 hours prior to start of treatment. 5. Hemoglobin < 7g/dL assessed within 24 hours prior to start of treatment. 6. Known hemolytic disease. 7. Known thrombosis or acute thromboembolic events (TEEs) or known medical history of 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 COVID-19 infection (e.g. history of thrombophilia). 8. 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 (details in Appendix 3: Estimated Glomerular Filtration Rate). 9. Subject with end stage renal disease (ESRD), or known primary focal segmental glomerulosclerosis (FSGS). 10. Known severe lung diseases interfering with COVID-19 therapy (e.g. COPD (GOLD stage III-IV / Group D), severe interstitial lung disease, cystic fibrosis, idiopathic pulmonary fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer). 11. Known decompensated heart failure (New York Heart Association class III–IV). 12. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh C score ≥ 9 points), or hepatocellular carcinoma. 13. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin. 14. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA. 15. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months. 16. Known human immunodeficiency virus infection. 17. Life expectancy of less than 90 days, according to the Investigator’s clinical judgment, because of medical conditions neither related to COVID-19 nor to associated medical complications. 18. Morbid obesity with high body mass index ≥ 40 kg/m², or malnutrition with low body mass index < 16 kg/m². 19. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before entering the trial. 20. Known treatment with exploratory selective immune suppressors (cytokine inhibitors, cytokine receptor inhibitors, kinase inhibitors) during the last 10 days before entering the trial. 21. Known treatment with fluoroquinolone preparations, during the last 5 days before entering the trial. 22. Known treatment with any type of interferon during the last 21 days before entering the trial. 23. Known treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of acute COVID-19. 24. Participation in another interventional clinical trial within 30 days before entering, or previous participation in this clinical trial. 25. Employee or direct relative of an employee of the contract research organization, the trial site, or Biotest.

2

Biotest AG

18

100

Argentina;Austria;Belgium;Brazil;Chile;Colombia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Turkey;United Kingdom

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

13

Composite primary endpoint: Deterioration / mortality rate

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

Phase 3

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