EUCTR2022-000736-37-HU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 moderate or severe COVID-19 - TRICOVID
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 334
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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) 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.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 134
排除标准
- •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.
研究者
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