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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05729217
Other study ID # Children COVID Symptoms
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date January 31, 2024

Study information

Verified date February 2023
Source GlobalMD Organization Network Corp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5000
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
SBQ-LC survey
Symptom burden questionnaires of Long COVID

Locations

Country Name City State
China Capital Institute of Pediatrics Beijing

Sponsors (2)

Lead Sponsor Collaborator
Tim Shi Capital Institute of Pediatrics, China

Country where clinical trial is conducted

China, 

Outcome

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