NCT04477993终止2 期
Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection
Vanderson Geraldo Rocha1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- A composite outcome of death or ICU admission or mechanical ventilation at day 14.
研究概览
简要总结
The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
- •PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air.
排除标准
- •Symptom onset > 14 days;
- •Neutrophil count < 1,000/mm3;
- •Platelets < 50,000/mm3;
- •ICU care at enrollment;
- •On invasive mechanical ventilation at enrollment;
- •Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
- •Uncontrolled arterial hypertension;
- •Current or previous use of systemic immunosuppressive therapy in the last 30 days;
- •Pregnancy or lactation;
- •Estimated creatinine clearance < 30 mL/min or receiving CRRT or intermittent hemodialysis;
- •Allergy to ruxolitinib;
- •Active tuberculosis;
- •HIV seropositivity;
- •Prior history of progressive multifocal leukoencephalopathy;
- •Use of any JAK inhibitor in the last 30 days before study enrollment;
- •Not qualifying according to investigators' perception.
研究组 & 干预措施
Experimental Group - ruxolitinib
Experimental
Ruxolitinib 5 mg PO b.i.d. for 14 days
干预措施: Janus Kinase Inhibitor (ruxolitinib) (Drug)
Placebo Group
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
A composite outcome of death or ICU admission or mechanical ventilation at day 14.
时间窗: 14 days
次要结局
- Change in troponin [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in ADAMTS-13 [%] from baseline to days 14 and 28(14 and 28 days)
- Time to treatment failure(28 days)
- Overall survival at days 14 and 28(14 and 28 days)
- Change in ferritin levels [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28(14 and 28 days)
- Secondary hemophagocytic syndrome rate(28 days)
- Change in C reactive protein levels [mg/L] from baseline to days 14 and 28(14 and 28 days)
- Change in glucose levels [mg/dL] from baseline to days 14 and 28(14 and 28 days)
- Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28(14 and 28 days)
- Cumulative incidence of mechanical ventilation at days 14 and 28(14 and 28 days)
- Duration of hospital stay(28 days)
- Duration of mechanical ventilation(28 days)
- Duration of non-invasive ventilation(28 days)
- Incidence of discontinuation of oxygen supplementation at days 14 and 28(14 and 28 days)
- Rate of grade 1-2 and 3-5 emerging adverse events at day 28(28 days)
- Change in d-dimer levels [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in prothrombin time ratio from baseline to days 14 and 28(14 and 28 days)
- Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28(14 and 28 days)
- A composite outcome of death or ICU admission or mechanical ventilation at day 28(28 days)
- Cumulative incidence of ICU admission rate at days 14 and 28(14 and 28 days)
- Duration of ICU stay(28 days)
- Cumulative incidence nosocomial infection rate at days 14 and 28(14 and 28 days)
- Cumulative dose of methylprednisolone at days 14 and 28(14 and 28 days)
- Change in PaO2/FiO2 ratio from baseline to days 14 and 28(14 and 28 days)
- Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28(14 and 28 days)
- Change in alanine aminotransferase [U/L] from baseline to days 14 and 28(14 and 28 days)
- Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28(14 and 28 days)
- Change in creatinine levels [mg/dL] from baseline to days 14 and 28(14 and 28 days)
- Change in bilirubin [mg/dl] from baseline to days 14 and 28(14 and 28 days)
- Change in von Willebrand multimeters from baseline to days 14 and 28(14 and 28 days)
- Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28(14 and 28 days)
- Change in hemoglobin levels [g/dL] from baseline to days 14 and 28(14 and 28 days)
- Change in partial thromboplastin time ratio from baseline to days 14 and 28(14 and 28 days)
- Change in CPK-MB [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28(14 and 28 days)
- Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28(14 and 28 days)
- Change in E-selectin levels [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in P-selectin levels [ng/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28(14 and 28 days)
- Change in circulating microparticles from baseline to days 14 and 28(14 and 28 days)
- Change in endothelin [fmol/mL] from baseline to days 14 and 28(14 and 28 days)
- Change in thromboelastography from baseline to days 14 and 28(14 and 28 days)
研究者
Vanderson Geraldo Rocha
Full Professor
University of Sao Paulo General Hospital
研究点 (1)
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