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临床试验/NCT04325919
NCT04325919Unknown不适用

Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年2月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul KS Chan

Professor

Chinese University of Hong Kong

研究点 (1)

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