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

Coronavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325919
• Other study ID #: COVID-19 study 2020.076
• Status: Recruiting
• Start date: February 24, 2020
• Est. completion date: June 17, 2023

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: Paul CHAN
• Phone: +852 35053339
• Email: paulkschan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 17, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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