NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Viral evolution
研究概览
简要总结
In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .
详细描述
This study aims to recruit adult persons with diagnostically confirmed Corona-Virus- Disease-19 (COVID-19) infection and with different disease manifestation who are included into diagnostic or therapeutic care at the University Hospital Tübingen (UKT).
The COVID-19 Next-Generation-Sequencing (NGS) study aims to cover as many patients in Germany as possible. It is expected to include in Phase 1 (pilot study): 250 patients with different disease manifestation (extreme phenotypes) and individual risk factors by whole genome analysis Phase 2 (verification study): 1.000 clinically well-defined patients to ensure a broader range of overlapping phenotypes, to verify data from the pilot study.
Phase 3 (confirmation study): > 10.000 patients to increase the power (anticipated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- •COVID-19 infection confirmed
- •COVID-19 disease manifestation
- •Age > 18 years
排除标准
- •Missing informed consent of the patient/ legal guardian/ relatives
结局指标
主要结局
Viral evolution
时间窗: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
The change in the genetic makeup of a virus population (measured in numbers) as the viruses mutate and multiply over time at different time points
次要结局
- Immune response(Day 1, Day 3-5, Day 7-9, 48 hours after recovery)
- Disease severity(Day 1, Day 3-5, Day 7-9, 48 hours after recovery)