Phase IIb Prospective, Multi-center, Randomized, Parallel, Double Blind, Placebo Controlled Trial to Evaluate Defibrotide Intravenous Infusion in the Prevention and Treatment of COVID-19 Respiratory Distress and Cytokine Release Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Clinical improvement.
研究概览
简要总结
Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the Cytokine balance, which is decisive in preventing multiorgan failure and death in patients with SARS-CoV-2 infection with clinical status grade 4 or 5 according to the WHO classification
详细描述
Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the Cytokine balance, which is decisive in preventing multiorgan failure and death in patients with SARS-CoV-2 infection with clinical status grade 4 or 5 according to the WHO classification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
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
- •Acceptance of participation in the study by the patient or legal representative.
- •Patients of any gender, 18 years or older.
- •Confirmed diagnosis by PCR+ of SARS-CoV-2 infection.
- •COVID-19 positive patients WHO grades 4, 5 or
- •Grade 4: hospitalized requiring oxygen therapy.
- •Grade 5: hospitalized requiring high-flow oxygen therapy, noninvasive mechanical ventilation, or both.
- •Levels of IL-6 ≥ 3 times the upper limit of normality
排除标准
- •Acute bleeding.
- •Thrombolytic treatment and anticoagulant treatment at therapeutic doses.
- •Pregnancy or lactation.
- •Patients with active malignant tumour, other serious systemic or neuropsychiatric diseases.
- •Patients participating in other clinical trials in the last month.
- •Inability to give informed consent or to accomplish the requirements of the diagnostic tests.
- •Patients with hypersensitivity to Defibrotide.
研究组 & 干预措施
Defibrotide + standard therapy
Defibrotide + standard therapy
干预措施: Defibrotide (Drug)
Placebo
Placebo + standard therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical improvement.
时间窗: 7,15, 30 day
Number of days that the patient maintains the clinical improvement. The patient achieves a change of al least 1 category on WHO scale.
次要结局
- Clinical improvement by NEWS2 scales(7, 15, 30 and 60 Day)
- Radiological response(7, 15, 30 and 60 Day)
- 1. Mortality rate(: up to 30 days)
- Biologic response(7, 15, 30 and 60 Day)
- Collection and storage of biological samples(15,30 days)
- Rate os serious adverse events .(7, 15, 30 and 60 Day)
- Clinical improvement by WHO(7, 15, 30 and 60 Day)