Development and Verification of a New Coronavirus Multipl... | NCT04311398

Studies
Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

NCT04311398

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

May 14, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

New QIAstat-Dx fully automatic multiple PCR detection platform

Countries

China

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2020Estimated

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Mar 14, 2020

First Submission Date that Met QC Criteria

Mar 14, 2020

First Posted Date

Mar 17, 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

May 13, 2020

Last Update Posted Date

May 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wen-hong Zhang, Chief of dpartment of infectious disease, Huashan HospitalPrincipal Investigator

Lead Sponsor

Huashan HospitalOTHER

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

Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

Detailed Description

COVID-19 has not been well suppressed, and became a pandemic within 3 months globally is mainly because of the virus characteristic in the following aspects:

Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious
Strong transmissibility, virus can be transmitted through aerosol
Difficulty distinguishing infected patients from other pathogenic infections
High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.

Therefore, this project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Respiratory infection group		Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University	Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform

Interventions

Name	Type	Description	Arm Group Labels	Other Names
New QIAstat-Dx fully automatic multiple PCR detection platform	Diagnostic Test	We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in Huashan Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenhong Zhang, Doctor	Contact	13801844344		zhangwenhong@fudan.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan Hospital of Fudan University		Shanghai	Shanghai Municipality	200040	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

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

Not provided