Coronavirus Disease 2019 (COVID-19) Study of Hospitalized... | NCT04325919

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

NCT04325919

Sponsor

Chinese University of Hong Kong

Status

Unknown status

Last Update Posted

Mar 10, 2022Actual

Enrollment

170Estimated

Phase

Not provided

Conditions

Coronavirus Infections

Interventions

No intervention

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2020Actual

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

Jun 17, 2023Estimated

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2022

Last Update Posted Date

Mar 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul CHAN	Contact	+852 35053339		paulkschan@cuhk.edu.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital	Recruiting	Shatin			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D000086382	COVID-19

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

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Browse Branches

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