EUCTR2020-002345-42-FR进行中（未招募）1 期
A randomized, placebo controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19 - ESsCOVID
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
- 114
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 authorized representative or informed verbal or administration consent due to pandemic situation, in compliance with all local legal requirements.
- •2. Male or female subject =18 years of age.
- •3. Laboratory-confirmed SARS-CoV-2 infection.
- •4. Diagnosis of community-acquired severe COVID-19 within 5 days after hospital-admission, with severe defined as:
- •o Need for non-invasive ventilation (NIV), or high-flow oxygen therapy (score =5 on the 9-category ordinal scale).
- •o At least one clinical respiratory parameter:
- •dyspnea, respiratory frequency =30/min, SpO2 =93%, 100 mmHg < PaO2/FiO2 =300 mmHg, lung infiltrates >50% within 24 to 48 hours.
- •o At least one measurement of C-reactive protein =50 mg/L within 18 hours prior to start of treatment.
- •5. Subject must receive SoC treatment for COVID-19.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •2. Subjects that deteriorated to score >5 on the 9-category ordinal scale (e.g. receiving invasive mechanical ventilation (IMV), and/or extracorporeal membrane oxygenation (ECMO)) or subjects that improved to score <5 prior to randomization.
- •3. Severe neutropenia (neutrophil count <500/mm³) assessed within 18 hours prior to start of treatment.
- •4. Thrombocytopenia (platelet count <30,000/mm³) assessed within 18 hours prior to start of treatment.
- •5. Hemoglobin <7g/dL assessed within 18 hours prior to start of treatment.
- •6. Known hemolysis.
- •7. Known thrombosis or 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 the previous 3 months or those subjects particularly at risk for TEEs (e.g. history of thrombophilia, permanent immobilization, or permanent paralysis of the lower extremities) caused by other reasons than COVID-19.
- •8. Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² assessed within 18 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. 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.
- •15. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months.
- •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. Obesity (body mass index =40 kg/m²), a body weight of more than 123 kg, or anorexia (body mass index <16 kg/m²).
研究者
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