Viral Excretion Among COVID-19 Omicron Recurrence Patients | NCT05470426

Studies
Viral Excretion Among COVID-19 Omicron Recurrence Patients

NCT05470426

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Jul 22, 2022Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

COVID-19 Recurrence
Surface Contamination

Interventions

COVID-19 Omicron Recurrence

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

Jul 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

Jul 2022Estimated

Primary Completion Date

Jul 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Jul 20, 2022

First Submission Date that Met QC Criteria

Jul 20, 2022

First Posted Date

Jul 22, 2022Actual

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

Jul 20, 2022

Last Update Posted Date

Jul 22, 2022Actual

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 study analyzes the viral nucleic acid excretion and its influencing factors of SARS-COV-2 Omicron recurrence patients.

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

35Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 Omicron Recurrence	Other	COVID-19 Omicron Recurrence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COVID-19 Omicron Recurrence	COVID-19 Omicron Recurrence	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with nucleic acid detection N gene and ORF gene Ct value < 40 after discharge from hospital
Being able to provide basic information, living habits, vaccination information, admission information

Exclusion Criteria:

Single gene target positive
Patients with incomplete baseline data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with COVID-19 Omicron Recurrence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ya Yang, PhD	Contact	68383362		yangya@renji.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital	Recruiting	Shanghai		200123	China

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