Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong

• Conditions: Coronavirus Infections

• Registration Number: NCT04325919
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-24
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10
• Primary Completion: 2023-02-28
• Study Completion: 2023-06-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19
• Controls are patients admitted for community-acquired pneumonia

Exclusion Criteria

• Patients who refuse to consent for study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiological	6 months	Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.
Clinical	6 months	Patients' treatment and management during hospitalization.
Virological	6 months	Serial viral load changes during hospitalization.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong