Coronavirus InfectionsNCT04325919
Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong
An observational study of Coronavirus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections
- How many people
- 170 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Feb 2020to 17 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19
- Controls are patients admitted for community-acquired pneumonia
Who cannot join
- Patients who refuse to consent for study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
+852 35053555
About this study
Official title: Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
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:
Read more
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.
- Conditions
- Coronavirus Infections
- Being tested
- No intervention
- Keywords
- SARS-CoV-2, Coronavirus disease 2019
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical
Patients' treatment and management during hospitalization.
Measured: 6 months
Virological
Serial viral load changes during hospitalization.
Measured: 6 months
Microbiological
Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start24 Feb 2020
- Primary completion28 Feb 2023 (estimated)
- Study completion17 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul KS Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325919
- Sponsor's protocol ID
- COVID-19 study 2020.076
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04325919
- Acronym / sponsor ID
- COVID-19 study 2020.076
- Conditions
- Coronavirus Infections
- Keywords
- SARS-CoV-2, Coronavirus disease 2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 17 Jun 2023 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19
- Controls are patients admitted for community-acquired pneumonia
Key exclusion criteria (1 listed)
- Patients who refuse to consent for study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul CHAN (+852 35053339, paulkschan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.