A Follow-up Study of Asymptomatic Infections and Diagnose... | NCT05387304

Studies
A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai

NCT05387304

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

May 24, 2022Actual

Enrollment

250,000Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

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 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2022Actual

Primary Completion Date

May 31, 2032Estimated

Completion Date

May 31, 2032Estimated

First Submitted Date

May 23, 2022

First Submission Date that Met QC Criteria

May 23, 2022

First Posted Date

May 24, 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

May 23, 2022

Last Update Posted Date

May 24, 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

This study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed 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

250,000Estimated

Label	Type	Description	Intervention Names
COVID-19 infections		SARS-Cov-2 RNA postive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
long-term outcomes，changes of clinical characteristic and social psychology	the 3rd，6th，9th month，average one year discharge from hospital	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SARS-Cov-2-RNA positive
informed consent signed

Exclusion Criteria:

informed consent rejected

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

asymptomatic infections and diagnosed patients with COVID-19 in fangcang shelter hospitals in Shanghai

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Chen, Ph D	Contact	+8613917403314		cy11530@rjh.com.cn

Overall Officials

Name	Affiliation	Role
Guang Ning, Ph D	Ruijin Hospital	Principal Investigator
Erzhen Chen, Ph D	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital	Recruiting	Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

The data are not publicity available due to privacy and ethical restrictions

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