CTRI/2021/08/035514Other2 期
A randomized, double-blind, multicenter 2-arm, parallel-group, placebo-controlled study to investigate the efficacy and safety of intravenous imatinib mesylate in reducing the severity of hypoxemic respiratory failure in patients with critical COVID-19 receiving standard of care. - IMPRESS-COVID
Exvastat Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
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
入选标准
- •Male or female patients aged ââ?°Â¥18 years; Women of childbearing potential must have a negative serum pregnancy test to confirm eligibility, Provision of signed written informed consent from the patient or patientââ?¬•s legally acceptable representative, SARS-CoV-2 infection confirmed by RT-PCR laboratory test (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19), Meet Berlin definition for moderate ââ?¬â?? severe ARDS:
- •Ã¢â?¬Â¢Bilateral opacities ââ?¬â? not fully explained by effusions, lobar/lung collapse, or nodules
- •Ã¢â?¬Â¢Respiratory failure not fully explained by cardiac failure or fluid overload.
- •Ã¢â?¬Â¢PaO2/FIO2 ââ?°Â¤200 mmHg with PEEP ââ?°Â¥5 cmH2O; Patient requires intubation or is currently intubated and has been for ââ?°Â¤48 hours.
排除标准
- •Persistent septic shock ( >24 hours) with a Mean Arterial Pressure (MAP) ââ?°Â¤65 mm Hg and serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation and vasopressor use (norepinephrine >0.2 Ã?¼g/kg/min) for >6 hours, major trauma in the past 5 days, Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year,Pre-existing severe cardiopulmonary disease including, but not limited to, interstitial lung disease; severe COPD (GOLD Stage IV or FEV1 <30% predicted); heart failure (estimated left ventricular ejection fraction <40%); or a chronic lung condition requiring home oxygen treatment,An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g., severe malnutrition, severe neurological disease),Patients considered inappropriate for critical care (e.g., being considered for palliative care),Currently receiving extracorporeal membrane oxygenation (ECMO), Severe chronic liver disease with Child-Pugh score >12 (Appendix 1),White blood count <2.5 x 109/L, or Hemoglobin <4.0 mmol/L(6.5g/dL), or Platelets <50 x 109/L;ALT or AST >10x upper limit of normal (ULN) or bilirubin >3x ULN, Women who are pregnant or breast-feeding;
- •Use of drugs with strong CYP3A4 induction potential, such as carbamazepine, efavirenz, enzalutamide, phenobarbital, phenytoin, hypericum, mitotane, nevirapine, primidone, rifabutin and rifampicin;Inability of the ICU staff to initiate administration of study treatment within 48 hours of intubation; Enrolled in a concomitant clinical trial of an investigational medicinal product, In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments.
研究者
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