EUCTR2020-001236-10-BE进行中（未招募）1 期
COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 – a randomized, double --blind, placebo controlled, clinical trial in patients with severe Covid19 disease’ - CounterCovid Study
Amsterdam UMC0 个研究点目标入组 385 人开始时间: 2020年11月16日最近更新:
适应症
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
- 385
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
- •- Hospital admission with proven SARS2-Covid19 infection
- •- Hypoxemic respiratory failure (SaO2 <94%, PaO2 <9kPa)
- •- Ability to give informed consent.
- •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 186
排除标准
- •- Pre-existing chronic pulmonary disease
- •- Former diagnosis of Interstitial pulmonary disease
- •- Former diagnosis of COPD 4 or FEV1<30%pred
- •- Previous DLCO <45%
- •- Total lung capacity (TLC) < 60% of predicted
- •- Lung cancer with non-surgical treatment in last year
- •- Chronic home oxygen treatment
- •- Pre-existing heart failure with a known left ventricular ejection fraction <40%
- •- Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy or targeted radiotherpay in the last year
- •- Inability to provide informed consent
- •- Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
- •- Active liver disease, porphyria or elevations of serums transaminases >5 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- •- History or suspicion of inability to cooperate adequately.
- •- White blood count < 4.0^109/l
- •- Hemoglobin < 6.0 mmol/l
- •- Thrombocytes < 100^109/l
- •- Pregnant female subjects
- •- Breastfeeding female subjects
- •- Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine
- •- Concomittant use of chloroquine or hydroxychloroquine.
- •- QTc >500msec at baseline.
研究者
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