Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Microbiological
研究概览
简要总结
COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19.
Arm 1:
We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate.
Arm 2:
The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study.
Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls.
Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19
- •Controls are patients admitted for community-acquired pneumonia
排除标准
- •Patients who refuse to consent for study
结局指标
主要结局
Microbiological
时间窗: 6 months
Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.
Clinical
时间窗: 6 months
Patients' treatment and management during hospitalization.
Virological
时间窗: 6 months
Serial viral load changes during hospitalization.
次要结局
未报告次要终点
研究者
Paul KS Chan
Professor
Chinese University of Hong Kong
