EUCTR2022-000736-37-AT招募中1 期
A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with CAP including COVID-19 pneumonia. - TRICOVID
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Biotest AG
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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:
- •- 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 (CRP) = 50 mg/L and = 150 mg/L within 24 hours prior to start of treatment with IMP.
- •7. D-dimer = 3 mg/L and platelets = 130 x109/L within 24 hours prior to start of treatment with IMP.
- •8. Treatment with investigational medicinal product (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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •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 x109/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 acute 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 C 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, absolute 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 exploratory 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
研究者
相似试验
招募中
1 期
A study to test trimodulin in adult hospitalized patients with severe pneumoniaCTIS2022-501352-28-00BIOTEST AG569
进行中（未招募）
1 期
A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with CAP including COVID-19 pneumonia.EUCTR2022-000736-37-BEBiotest AG390
进行中（未招募）
2 期
Efficacy and safety of oral BT-11 in mild to moderate ulcerative colitislcerative colitisDigestive SystemUlcerative colitisISRCTN14296856andos Biopharma Inc.195
招募中
1 期
A study to test trimodulin in adult hospitalized patients with CAP including COVID-19 pneumonia.on-severe community-acquired pneumonia (CAP) or moderate or severe Coronavirus Disease 2019 (COVID-19)MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumonia Class: 10021881MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862CTIS2024-513002-60-00Biotest AG390
进行中（未招募）
1 期
This study is being conducted to evaluate efficacy and safety of Octreotide compared with Placebo via subcutaneous depot route in subjects with polycystic liver diseasePolycystic liver diseaseEUCTR2021-003764-27-NLCamurus AB69