EUCTR2020-001154-22-DK进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •- Age >= 18 years
- •- Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of
- •any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid)
- •and evidenced by chest X-ray or CT scan
- •- SpO2 <= 93% or PaO2/FiO2 < 300 mmHg.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •- Known severe allergic reactions to TCZ or other monoclonal antibodies
- •- Active TB infection
- •- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- •- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- •- Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within past 3 months
- •- Pregnant or lactating women
- •- Participating in other drug clinical trials (with possible exception of anti-viral trials)
- •- ANC < 1000/mm3
- •- Platelet count < 50,000/mm3
- •- ALT or AST > 10 x ULN
- •- Treatment with an investigational drug within 5 half-lives or 30 days
- •- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study.
研究者
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