COVID-19 Inflammatory Blood Biomarkers for Clinical Management, Prognosis and Evaluation of Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Inflammation
研究概览
简要总结
Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19 patients demonstrate two patient sub-types (called phenotypes). In one group the disease progresses slowly and patients have a low potential of developing mild respiratory failure, but in the other group, an exaggerated immune response (hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratory failure, termed acute respiratory distress syndrome. This syndrome is responsible for a large portion of COVID-19 associated mortality. Thus, determining links between hyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is of immediate importance. Blood samples will undergo a number of analyses to help us to understand as much as possible about COVID-19. We will also study any differences in physiologic and cytokine levels before and after patients are treated with immunomodulatory therapies as part of clinical care in COVID-19 patients.
详细描述
PURPOSES
- Determine the prevalence of a COVID-19 hyper-inflammatory "cytokine storm" phenotype in patients at Vancouver General Hospital
- Determine any potential links between cytokine storm and ARDS in COVID-19 patients
- Profile patients with mild and severe disease in an attempt to identify biomarkers that could be developed into a rapid test for triaging patients who require urgent care from those that will recover on their own
- Elucidate the impact of genetic variation on clinical outcomes from COVID-19
- Identify SARS-CoV-2 relevant RNAs
- To determine differences in physiologic and cytokine levels before and after patients are treated with immunomodulatory therapies as part of clinical care in COVID-19 patients.
HYPOTHESES
- Primary: Based off of previous reports, approximately 50% of COVID-19 patients will demonstrate a cytokine storm phenotype
- Secondary: a)Patients exhibiting cytokine storm will demonstrate a higher incidence of ARDS b)We will identify biomarkers for rapid testing c)Host gene variation will influence the clinical outcome from COVID-19 infection
JUSTIFICATION
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to VGH or SMH with confirmed COVID-19
- •Admitted to the High Acuity Unit or Intensive Care Unit at VGH or SMH
- •An arterial line is in place as part of clinical care. If arterial line is on longer insitu the sample will be collected to coincide with usual care blood collection. This will negate the need for additional venipuncture
排除标准
- •Those who do not meet inclusion criteria
结局指标
主要结局
Inflammation
时间窗: 24 hours
Interleukin 1b, 6, 10 and tumor necrosis factor alpha
Oxygenation
时间窗: 24 hours
Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)
次要结局
- Chronic Pulmonary outcomes(8 to 12 weeks after discharge)
- Pulmonary artery pressure using transthoracic echocardiography(8 to 12 weeks after discharge)
- Exertion(8 to 12 weeks after discharge)
- Quality of life assessment(8 to 12 weeks after discharge)
研究者
Myp Sekhon
Principal Investigator
University of British Columbia