Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mechanical ventilation-free days
研究概览
简要总结
Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS).
Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.
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
- 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
- •Age 18 or older
- •Positive revere transcription polymerase chain reaction (RT-PCR) for COVID-19 in a respiratory track sample
- •Acute (less than 36 hours) onset of moderate to severe ARDS, as defined by Berlin criteria:
- •Having pneumonia or worsening respiratory symptoms
- •Bilateral pulmonary infiltrates on chest imaging (X-ray of CT scan)
- •Pulmonary wedge pressure <18 mmHg or no clinical signs of left heart failure
- •Hypoxemia: arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2 ratio) <200mmHg, moderate dyspnea with signs of important respiratory workload, tachypnoea >30bpm
- •Rise of inflammatory biomarkers: C-reactive protein (CRP) >10 mg/L
排除标准
- •Patients with a known contraindication for anticoagulation
- •Pregnancy or breast feeding
- •Patient already included in another research study
- •Decision by a physician that involvement in the study is not in the patient's best interest
- •Failure to have patient's authorization. In case of a mechanical intubated patient, lack of authorization from a first line family member
- •Multi-organ failure
- •Patients treated with Tocilizumab at the time of start filtration
结局指标
主要结局
Mechanical ventilation-free days
时间窗: up to 28days
Number of ventilator-free days (VFDs) at day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment. For patients ventilated 28 days or longer and for ventilated subjects who die, VFD is 0
次要结局
- 30-day mortality(up to 30 days)
- length of ICU stay (days)(up to 30 days)
- length of hospital stay(up to 30 days)
- Duration of renal replacement and cathecolamines therapies(up to 30 days)
- Need for extracorporeal membrane oxygenation (ECMO) support(up to 30 days)
- multi-organ failure measured by the Sequential Organ Failure Assessment (SOFA) score(up to 30 days (measured on days 0, 1, 2, 3, 4, 5, 6, and the last day of mechanical ventilation))
研究者
Manuel Castellà
MD PhDHead of the Cardiovascular Surgery Department, Associate Professor, Principal Investigator
Hospital Clinic of Barcelona