NL-OMON49996已完成2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 386
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >18 years
- •- Hospital admission with proven SARS2-Covid19 infection
- •- Hypoxemic respiratory failure (SpaO2 <94% or, PaO2 <9kPa)
- •- Ability to give informed consent.
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
- •- 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 femae subjects (pregnancy test will be performed in all women of
- •childbearing age prior to inclusion)
- •- 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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