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

February 28, 2023 updated by: Tim Shi

Long COVID Symptoms in SARS-CoV-2-positive Children Aged 6-18 Years in China: a Consequential Observation Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Capital Institute of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 aged 7-12 years
Group 1 will mainly be primary school students from grade 1 to 6.
Other: SBQ-LC survey
Symptom burden questionnaires of Long COVID
Group 2 aged 13-15 years
Group 2 will mainly be middle school students from grade 13 to 15.
Other: SBQ-LC survey
Symptom burden questionnaires of Long COVID
Group 2 aged 16-18 years
Group 3 will mainly be high school students from grade 16 to 18.
Other: SBQ-LC survey
Symptom burden questionnaires of Long COVID

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tim Shi

Collaborators

Capital Institute of Pediatrics, China

Investigators

  • Study Director: Jun Ting Liu, MD, Capital Institute of Pediatrics, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Children COVID Symptoms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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