EUCTR2020-005447-23-NL进行中（未招募）1 期
A randomised, double-blind, placebo-controlled study to investigate the safety and efficacy of intravenous imatinib mesilate (Impentri®) in subjects with Acute Respiratory Distress Syndrome induced by COVID-19. - Intravenous imatinib for COVID-19-related ARDS.
Amsterdam Universitair Medische Centra, location VUmc0 个研究点目标入组 90 人开始时间: 2021年1月28日最近更新:
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
- •1. Age = 18 years;
- •2. Moderate-severe ARDS, as defined by Berlin definition for ARDS, and intubated for mechanical ventilation.
- •3. PCR positive for SARS-CoV2 within the current disease episode.
- •4. Provision of signed written informed consent from the patient or patient's legally authorised representative;
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Persistent septic shock (>24h) with a Mean Arterial Pressure (MAP) = 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation and vasopressor use (norepinephrine > 0.2 µg/kg/min) for > 6 hours;
- •2. Pre-existing chronic pulmonary disease, including: o Known diagnosis of Interstitial Lung disease
- •o Known diagnosis of COPD Gold IV or FEV1<30%pred o DLCO <45% (if test results are available)
- •o Total lung capacity (TLC) < 60% of predicted (if test results are available);
- •3. Chronic home oxygen treatment;
- •4. Pre-existing heart failure with a known left ventricular ejection
- •fraction <40%;
- •5. Active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year;
- •6. Currently receiving extracorporeal life support (ECLS);
- •7. Severe chronic liver disease with Child-Pugh score > 12;
- •8. Subjects in whom a decision to withdraw medical care is made (e.g.
- •palliative setting);
- •9. Inability of the ICU staff to initiate study drug administration within 48 hours of screening;
- •10. Known to be pregnant or breast-feeding;
- •11. Enrolled in a concomitant clinical trial of an investigational
- •medicinal product;
- •12. White blood count < 2.5x109/l;
- •13. Haemoglobin < 4.0 mmol/l;
- •14. Thrombocytes < 50x109/l;
- •15. The use of strong CYP3A4 inducers, including the following drugs:
- •Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;
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