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

NCT05729217 | Unknown

• 1 other identifier: Children COVID Symptoms
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptoms and Signs

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• aged below 6 years or above 18 years

Sponsors & Collaborators

• Tim Shi: lead
• Capital Institute of Pediatrics, China: collaborator

Study Sites (1)

Capital Institute of Pediatrics

Beijing, China

Location

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Ting Liu, MD

  Capital Institute of Pediatrics, China

  STUDY DIRECTOR

• Tim Shi, MD, PhD

  GlobalMD Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)