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

Overview

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.

Full Title of Study: “Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2023

Interventions

  • Other: No intervention
    • No intervention

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul KS Chan, Professor – Chinese University of Hong Kong
  • Overall Contact(s)
    • Paul CHAN, +852 35053339, paulkschan@cuhk.edu.hk

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