Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS A Single-arm, Open-label, Proof of Concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
详细描述
This clinical trial is an open-label trial of ruxolitinib for the treatment of severe COVID-19 to assess its efficacy and safety.
Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of Janus kinase (JAK)1 and JAK2, with modest to marked selectivity against tyrosine kinase (TYK)2 and JAK3, respectively. Ruxolitinib interferes with the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.
Ruxolitinib (JAKAVI®) is currently approved in the European Union (EU) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (PMF) (also known as chronic idiopathic MF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) and for the treatment of adult patients with PV who are resistant to or intolerant of hydroxyurea (HU). In the US, ruxolitinib has been approved in the treatment of steroid refractory graft versus host disease post allogeneic stem cell transplantation.
Because many patients with severe respiratory disease due to COVID-19 have features consistent with the cytokine release syndrome (CRS) and increased activation of the JAK/STAT pathway, it is postulated that ruxolitinib might have a useful role in treating these patients.
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
- •Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- •has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to approved latest within 48-72 hours after registration)
- •Willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study
- •severe lung disease as defined by following:
- •Recent intubation
- •Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O
- •Serum LDH > 283 U/l
- •Ferritin above normal value
- •CT-scan: pulmonary infiltration compatible with Covid-19 disease
- •Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.
排除标准
- •Uncontrolled HIV infection
- •Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention)
- •Chronic kidney disease requiring dialysis
- •ALT/AST > 5 times the upper limit of normal.
- •Pregnancy or breast feeding.
- •Allergy to study medication
- •Simultaneous participation in another clinical trial with an experimental treatment
研究组 & 干预措施
Ruxolitinib treatment
Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days
干预措施: Ruxolitinib administration (Drug)
结局指标
主要结局
Overall survival
时间窗: 28 days after registration into trial
To determine the efficacy of ruxolitinib measured by overall survival
次要结局
- Tiffeneau-Pinelli index(Discharge from hospital (end of treatment))
- Assessment of the duration of ventilation support(registration until 90 days after registration into trial)
- cytokine storm(registration until 90 days after registration into trial)
- time on ICU(registration until 90 days after registration into trial)
- Forced vital capacity (FVC)(Discharge from hospital (end of treatment))
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(registration until 90 days after registration into trial)
- time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)(registration until 90 days after registration into trial)
- Rates of flow(Discharge from hospital (end of treatment))
- Gas exchange(Discharge from hospital (end of treatment))
- Forced expiratory volume in 1 second (FEV1)(Discharge from hospital (end of treatment))
- Overall survival(90 days after registration into trial)