Clinical trial NCT04325919: Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong
Official title: Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infections
Keywords: SARS-CoV-2
Coronavirus disease 2019
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with laboratory-confirmed COVID-19 in the Prince of Wales Hospital, Princess Margaret Hospital, United Christian Hospital, North District Hospital, Alice Ho Miu Ling Nethersole Hospital, Pamela Youde Nethersole Eastern Hospital, Ruttonjee Hospital, Queen Elizabeth Hospital, and may extend to other hospitals when more cases are detected. The Public Health Laboratory Service, Department of Health, will be invited to assist specimen retrieval and 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical
timeFrame: 6 months
measure: Virological
timeFrame: 6 months
measure: Microbiological
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: