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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04325919
Collaborator
(none)
170
Enrollment
1
Location
39.7
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date :
Feb 24, 2020
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jun 17, 2023

Outcome Measures

Primary Outcome Measures

  1. Clinical [6 months]

    Patients' treatment and management during hospitalization.

  2. Virological [6 months]

    Serial viral load changes during hospitalization.

  3. Microbiological [6 months]

    Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Sha Tin Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul KS Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04325919
Other Study ID Numbers:
  • COVID-19 study 2020.076
First Posted:
Mar 30, 2020
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paul KS Chan, Professor, Chinese University of Hong Kong
SARS-CoV-2
Coronavirus disease 2019
Additional relevant MeSH terms:
Coronavirus Infections
COVID-19

Study Results

No Results Posted as of Mar 10, 2022