Novel SARS-CoV-2 Point-of-care Testing | NCT05034978

Studies
Novel SARS-CoV-2 Point-of-care Testing

NCT05034978

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Feb 9, 2023Actual

Enrollment

150Actual

Phase

Not provided

Conditions

SARS-CoV2 Infection

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failure in enrolling eligible subjects during COVID-19 outbreaks

Expanded Access Info

Start Date

Mar 16, 2021Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Aug 29, 2021

First Submission Date that Met QC Criteria

Aug 29, 2021

First Posted Date

Sep 5, 2021Actual

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

Feb 7, 2023

Last Update Posted Date

Feb 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shui-Shan Lee, MD, Research Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of the project is to study the feasibility of implementing a novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection. A CRISPR-based detection kit would be piloted for testing of suspected SARS-CoV-2 infection in healthcare setting, with the objectives of evaluating the performance of the new test in the detection of SARS-CoV-2, and assessing the practicability of the new test for diagnosing SARS-CoV-2 infection in healthcare settings.

Detailed Description

A CRISPR-based lateral flow assay (LFA) detection kit would be designed and developed for testing for the presence of SARS-CoV-2. The aim of the project is to study the feasibility of implementing the novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection in health service setting, with the following objectives: (b) Evaluation of the performance of novel POCT in comparison with conventional quantitative PCR in diagnosis SARS-CoV-2 infection and (c) Assessment of the practicability of LFA-CRISPR-based tests in the operating environments in healthcare settings.

Patients who are admitted to the isolation wards of Prince of Wales Hospital, Hong Kong would be invited to join the study. A total of 600 persons with suspected SARS-CoV-2 infection presenting with different symptomatology and epidemiological history will be recruited. Nasal, deep saliva and/or mouth gargle samples will be collected from all recruited subjects in accordance with standard clinical protocol. The samples would be tested for SARS-CoV-2 by the new Point-of-care test, in parallel with standard diagnostic testing of the hospital.

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

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	evaluating the performance of a novel point-of-care test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test performance	agreement of point-of-care test result and conventional test	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients admitted to isolation wards of the hospital who are
of age of 18 or above;
presentation with symptoms of COVID-19 and/or
demonstration of exposure risk to SARS-CoV-2 infection.

Exclusion Criteria:

inability to communicate in English or Chinese;
known history of mental illness;
prisoners.

Accepts Healthy Volunteers

Not provided

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

persons with exposure risk to SARS-CoV-2 infection who subsequently test positive or negative to conventional PCR-based testing for the diagnosis of the infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong		Hong Kong		0000	Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participants data are not collected

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

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