PROSAIC-19 - Prospective Longitudinal Assessment in a COVID-19 Infected Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection
研究概览
简要总结
DESIGN Longitudinal prospective observational multicentre study.
Primary objective:
Understand the immune mechanisms driving COVID-19 disease in patients with a history of lung disease
详细描述
INTRODUCTION
1.1 BACKGROUND
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection is a new rapidly spreading infectious disease with no proven treatment options. The virus causes a spectrum of disease ranging from mild coryzal symptoms to severe respiratory compromise requiring ventilatory support. Guidance from Public Health England identifies several groups that are at risk of severe disease including the elderly and individuals with chronic lung disease. Additionally, there is also debate over the role of corticosteroids with some hospital guidelines recommending their use despite WHO guidance contradicting this due to concerns that they may impair antiviral immunity and worsen disease. The mechanisms driving severity of disease in certain individuals infected with COVID-19 are poorly understood. We urgently need to understand these mechanisms to facilitate rapid development of novel effective therapies and vaccines
1. Immunosusceptibility to severe COVID-19 disease
There are several putative mechanisms through which SARS-CoV-2 could drive greater disease severity in pre-disposed individuals. These include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients ≥16 years old with confirmation of COVID-19
- •All patients ≥ 16 years old with chronic lung disease (CF, non-CF bronchiectasis, asthma, COPD or Idiopathic Pulmonary Fibrosis) or with no evidence of prior chronic lung disease
- •Healthy volunteers
排除标准
- 未提供
研究组 & 干预措施
Healthy volunteers with COVID and no Lung disease ( n =115)
Blood tests
COVID -19 with chronic lung disease
Subjects with swab confirmed COVID-19 and underlying chronic lung disease (n=20)
干预措施: Blood tests sputum, nasal lavage and brushing (Other)
COVID-19 without chronic lung disease
Subjects with swab confirmed COVID-19 and no chronic lung disease (n=60)
Severe (n=46) (defined by presence of ARDS, sepsis or severe pneumonia)
Mild/Moderate ( n =30) (absence of severe criteria)
干预措施: Blood tests sputum, nasal lavage and brushing (Other)
Chronic Lung disease
Subjects with chronic lung disease (identified as requiring shielding based on severity) but no COVID-19 (n=18)
Unable to recruit sufficient patients with chronic lung disease and no COVID
干预措施: Blood tests sputum, nasal lavage and brushing (Other)
Healthy volunteers
Healthy subjects with no COVID-19 (n= 68)
干预措施: Blood tests sputum, nasal lavage and brushing (Other)
结局指标
主要结局
Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection
时间窗: Through study completion an average of 1 year
Anti-viral cytokine protein concentration in blood samples by ELISA
Anti-viral cytokines profiles within sputum samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection
时间窗: Through study completion an average of 1 year
Inflammatory cytokine protein concentration in sputum samples by ELISA
Anti-viral cytokine profiles within nasal lavage samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection associated with susceptibility to severe COVID-19 infection
时间窗: Through study completion an average of 1 year
Inflammatory cytokine protein concentration in nasal lavage samples by ELISA
Expression of inflammatory gene expression in upper respiratory epithelial airway cells using nasal brush specimens in chronic respiratory disease associated with susceptibility to severe COVID-19 infection
时间窗: Through study completion an average of 1 year
Inflammatory gene expression in upper airway respiratory epithelial cells by RNA sequencing.
次要结局
- Identify the T cell antigens and B cell epitopes in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)
- Identify endothelial function in chronic respiratory disease associated with susceptibility to severe COVID-19 infection using EndoPAT testing(Through study completion an average of 1 year)
- Endothelial cell inflammation biomarkers in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)
- Identify sputum 16S rRNA and ITS sequences in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)
- Identify nasal lavage 16S rRNA and ITS sequences in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)
- Peripheral blood mononuclear cell (PBMC) interferon mediated immune responses to pathogen recognition receptor agonists in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)
- Identify quality of life markers in chronic respiratory disease associated with susceptibility to severe COVID-19 infection(Through study completion an average of 1 year)