Symptoms and SignsNCT05729217
Long COVID Symptoms in SARS-CoV-2-positive Children in China
An observational study of Symptoms and Signs, run by Tim Shi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Symptoms and Signs
- What is being tested?
- SBQ-LC survey
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- infected with SARS-CoV-2 as self-reported PRC test or antigen test positive or have symptoms, but without Covid-19 test.
Who cannot join
- aged below 6 years or above 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Symptoms and Signs
- Being tested
- SBQ-LC survey
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBQ-LC surveyOther
Symptom burden questionnaires of Long COVID
| Study group | Role | What they receive |
|---|---|---|
| Group 1 aged 7-12 years | Group 1 will mainly be primary school students from grade 1 to 6. Receives: Other: SBQ-LC survey | |
| Group 2 aged 13-15 years | Group 2 will mainly be middle school students from grade 13 to 15. Receives: Other: SBQ-LC survey | |
| Group 2 aged 16-18 years | Group 3 will mainly be high school students from grade 16 to 18. Receives: Other: SBQ-LC survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
long symptoms of SARS-CoV-2
the prevalence of long-lasting symptoms, the duration and intensity of symptoms
Measured: 6 to 12 weeks
absences from school
number of sick days or absences from school, and psychological and social outcomes.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tim Shi
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Institute of Pediatrics, China
- Responsible party
- Sponsor-investigator, Tim Shi, GlobalMD Organization Network Corp
- Investigators
- Jun Ting Liu, MD, Study director, Capital Institute of Pediatrics, ChinaTim Shi, MD, PhD, Principal investigator, GlobalMD Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729217
- Sponsor's protocol ID
- Children COVID Symptoms
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID Symptoms in SARS-CoV-2-positive Children Aged 6-18 Years in China: a Consequential Observation Study
- ClinicalTrials.gov ID
- NCT05729217
- Acronym / sponsor ID
- Children COVID Symptoms
- Conditions
- Symptoms and Signs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tim ShiUniversity, hospital or other
- Collaborators
- Capital Institute of Pediatrics, China
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 aged 7-12 years | – | Other: SBQ-LC surveyGroup 1 will mainly be primary school students from grade 1 to 6. |
| Group 2 aged 13-15 years | – | Other: SBQ-LC surveyGroup 2 will mainly be middle school students from grade 13 to 15. |
| Group 2 aged 16-18 years | – | Other: SBQ-LC surveyGroup 3 will mainly be high school students from grade 16 to 18. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- infected with SARS-CoV-2 as self-reported PRC test or antigen test positive or have symptoms, but without Covid-19 test.
Key exclusion criteria (1 listed)
- aged below 6 years or above 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBQ-LC surveySymptom burden questionnaires of Long COVID | Other | Group 1 aged 7-12 years, Group 2 aged 13-15 years, Group 2 aged 16-18 years |
Primary outcome
long symptoms of SARS-CoV-2
Time frame: 6 to 12 weeks
the prevalence of long-lasting symptoms, the duration and intensity of symptoms
absences from school
Time frame: 24 weeks
number of sick days or absences from school, and psychological and social outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ting Liu, MD study director
Capital Institute of Pediatrics, China
Tim Shi, MD, PhD principal investigator
GlobalMD Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptoms and Signs, run by Tim Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long symptoms of SARS-CoV-2 (time frame: 6 to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.