Long COVID Symptoms in SARS-CoV-2-positive Children in China | NCT05729217

Studies
Long COVID Symptoms in SARS-CoV-2-positive Children in China

NCT05729217

Sponsor

Tim Shi

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Symptoms and Signs

Interventions

SBQ-LC survey

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Jan 31, 2024Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

Feb 13, 2023

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 15, 2023Actual

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 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Name	Class
Capital Institute of Pediatrics, China	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. The participants will be asked to fill in Long COVID symptom burden questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

Detailed Description

The participants will be asked to fill in SBQ-Long COVID symptom burden survey questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

The survey questionnaires will be filled every two weeks after the participants have been tested SARS-CoV-2 positive.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1 aged 7-12 years	Group 1 will mainly be primary school students from grade 1 to 6.	Other: SBQ-LC survey
Group 2 aged 13-15 years	Group 2 will mainly be middle school students from grade 13 to 15.	Other: SBQ-LC survey
Group 2 aged 16-18 years	Group 3 will mainly be high school students from grade 16 to 18.	Other: SBQ-LC survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SBQ-LC survey	Other	Symptom burden questionnaires of Long COVID	Group 1 aged 7-12 years Group 2 aged 13-15 years Group 2 aged 16-18 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
long symptoms of SARS-CoV-2	the prevalence of long-lasting symptoms, the duration and intensity of symptoms	6 to 12 weeks
absences from school	number of sick days or absences from school, and psychological and social outcomes.	24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infected with SARS-CoV-2 as self-reported PRC test or antigen test positive or have symptoms, but without Covid-19 test.

Exclusion Criteria:

aged below 6 years or above 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

any children (aged from 6 to 18 years) who had infected with SARS-CoV-2 in Dec. 1st, 2022 to Jan 15th, 2023.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Ting Liu, MD	Capital Institute of Pediatrics, China	Study Director
Tim Shi, MD, PhD	GlobalMD Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Capital Institute of Pediatrics		Beijing			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
D012816	Signs and Symptoms

Ancestor Terms

ID	Term
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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