NCT04378920已完成1 期
A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes
Institut de cancérologie Strasbourg Europe2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年4月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
研究概览
简要总结
This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.
详细描述
Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing.
Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from the patient or patient's legal representative must be obtained prior to any procedures, as the likelihood of patients being able to provide consent is very limited
- •Patients must be ≥ 18 years old
- •Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2 ratio of less than 200 mm Hg
- •Patient must be under artificial ventilation support (including patient under OptiflowTM Nasal High Flow device or an equivalent device)
- •Patient must have a life expectancy of at least 24 hours
- •Patients should have normal liver function as defined by ALT, AST and alkaline phosphate less than 3 ULN for the institution
- •Patient must have platelet count above >100,000 cells/mm3, hemoglobin > 8 g/dL and an absolute neutrophil count (ANC) of > 1000 cells/mm3
- •Patients requiring dialysis due to renal impairment in cohort 3
排除标准
- •Patient is enrolled in any other therapeutic clinical trial with the same endpoints. All observational studies or study with limited invasive methods (Pharmacokinetic studies, monitoring of virus charges studies, biological monitoring studies ....) are allowed
- •Patient is pregnant or breast-feeding
- •Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its excipients
- •Patients with hemoglobinopathy
- •Patients receiving extracorporeal membrane oxygenation (ECMO)
研究组 & 干预措施
4L6715
Experimental
exploring various doses of LEAF-4L6715
干预措施: LEAF-4L6715 (Drug)
结局指标
主要结局
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
时间窗: 24 hours
次要结局
- proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg(24, 48 and 72 hours)
- all cause mortality(28 days)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract CancerAdvanced Biliary Tract CancerExtrahepatic CholangiocarcinomaGallbladder CarcinomaIntrahepatic CholangiocarcinomaNCT05009953CSPC Ouyi Pharmaceutical Co., Ltd.17
已完成
2 期
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung CancerAdvanced Non-small Cell Lung Cancer (NSCLC)NCT01101334Daiichi Sankyo90
已完成
2 期
Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal MelanomaUveal MelanomaNCT01034787AHS Cancer Control Alberta11
进行中（未招募）
1 期
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid TumorSolid NeoplasmsNCT04078295Eisai Co., Ltd.125
终止
2 期
Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaRecurrent Adult Acute Myeloid LeukemiaNCT02337478Wake Forest University Health Sciences5