EUCTR2020-001767-86-IE进行中（未招募）1 期
An open-label, multi-centre, randomised trial comparing different doses ofsingle-dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infectionwith evidence of progressive decline in respiratory function and evolving systemic inflammationon time to intubation, non-invasive ventilation and/or all-cause mortality
niversity College Dublin0 个研究点目标入组 90 人开始时间: 2020年4月15日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Confirmed SARS-CoV2 infection (as defined by positive PCR)
- •Evidence of hyper inflammatory state as evidenced by at least
- •three of the following:
- •o Documented temperature >38°C in the past 48 hours
- •o IL6 >40 pg/ml, or in its absence D-dimer >1.5 µgFEU
- •o Elevated CRP (>100mg/L) and/or a three-fold
- •increase since presentation
- •o Elevated ferritin X5 ULN
- •o Elevated LDH (above the ULN)
- •o Elevated fibrinogen (above the ULN)
- •Pulmonary infiltrates on chest imaging
- •Moderate to severe respiratory failure as defined by
- •PaO2/FiO2=300mmHg
- •Aged 18 years or older
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Primary or secondary immunodeficiency
- •Use of significant immunosuppressive therapy in the last 3
- •months (not including hydroxychloroquine or short course of
- •corticosteroids (defined as <400mg cumulative dose)
- •Active malignancy requiring treatment
- •Known active current or history of recurrent bacterial,
- •mycobacterial, fungal or viral infections including history of
- •untreated latent TB
- •History of diverticulitis or chronic ulcerative GI disease that
- •might predispose to GI perforation
- •Severe allergic reaction to monoclonal antibodies
- •Pregnancy or breast feeding
- •AST / ALT with values greater than 10 times normal levels or
- •history of significant liver disease that in the opinion of the
- •investigator precludes use of an investigational agent
- •Neutrophils < 0.5 x109/L
- •Platelets < 50x109/L
- •Documented, uncontrolled sepsis caused by pathogen(s)
- •other than COVID-19
- •Presence of co-morbidities (including cognitive impairment
- •and/or frailty) that, in the opinion of the investigator, should
- •preclude use of an investigational agent
- •Current skin or soft tissue infection not controlled by
- •antibiotics
- •Body weight = 30kg
研究者
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