- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05729217
Long COVID Symptoms in SARS-CoV-2-positive Children in China
Long COVID Symptoms in SARS-CoV-2-positive Children Aged 6-18 Years in China: a Consequential Observation Study
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Capital Institute of Pediatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
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.
|
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.
|
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
Sponsor
Collaborators
Investigators
- Study Director: Jun Ting Liu, MD, Capital Institute of Pediatrics, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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