COVID-19SPLaT-19NCT05422937
Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)
An observational study of COVID-19 and Pediatric ALL, run by Keele University at 1 site in United Kingdom.
Trial summary
Introduction: While there is a substantial body of knowledge about acute Covid-19 in children and young people (CYP), less is known about long-COVID, where symptoms continue beyond four weeks, particularly since the most recent wave of the Omicron variant and the UK childhood vaccination programme roll out. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pediatric ALL
- How many people
- 502 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2022to 2 Mar 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All CYP aged 8 years - 17 years \& 11 months (inclusive), registered at a participating general practice, will be invited to participate, subject to the eligibility criteria.
Who may be able to join
- All CYP aged 8 years - 17 years \& 11 months will be eligible for the study regardless of whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported LFD OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record.
- Children and adolescents (n≈20) aged 8 to 17 years, with evidence of Long COVID, as identified through participation in SPLaT cohort and defined as symptoms persisting longer than 4 weeks following an acute episode of COVID-19.
- Adults working with children and adolescents in roles including teaching, social work, and voluntary organisations, identified by our local networks (n≈8).
Who cannot join
- CYP aged 8-17 (inclusive) who have relevant dissent codes on their medical records, indicating that their records are not to be used for research. CYP who have declined consent for text messaging services will not be invited to the study. CYP younger than 8 years and older than 17 years and 11 months will not be invited to the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Keele University
Newcastle-under-Lyme, Staffordshire, ST5 5BG
About this study
Introduction:
While there is a substantial body of knowledge about acute Covid-19 in children and young people (CYP), less is known about long-COVID, where symptoms continue beyond four weeks, particularly since the most recent wave of the Omicron variant and the UK childhood vaccination programme roll out. This study aims to provide a picture of longer-term effects of an acute Covid-19 infection in CYP and identify their needs.
Read more
Methods and analysis:
The study comprises an observational prospective cohort study and a linked qualitative study. The cohort study will identify CYP aged 8-17 years in the West Midlands of England and, irrespective of Covid-19 status, invite them to complete an online questionnaire at point of recruitment, and after 3, 6, 9 and 12 months. CYP who have experienced long-term effects of COVID-19 will be invited to interview and, those who are currently experiencing symptoms, will be invited to record their experiences in a diary. Adults working in professional or third sector/voluntary roles with CYP will be invited to take part in a focus group to explore the perceived impact of Long-COVID on the wider experience of CYP. Approximately 900 participants will be needed for the cohort study to ensure the sample size is suitable, with approximately 20 CYP invited to interview and approximately 8 professionals invited to a focus group. Descriptive statistics will be used to describe incidence rates of symptoms and symptom resolution trajectories, and comparisons made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and development of Long-COVID at each follow-up point. Linear regression will be used to estimate associations between candidate predictors and poor outcome in terms of health-related quality of life, as described by the KIDSCREEN10. Qualitative data will be analysed thematically using the constant comparison method.
Ethics and dissemination:
Research Ethics Committee and Health Research Authority approvals will be sought. Information about where to seek support will be provided to participants to mitigate against risks of harm. Study findings will be presented at conferences and published in open access journals.
- Conditions
- COVID-19, Pediatric ALL
- Medical subject headings
- COVID-19, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and Young People aged 8-17 | All CYP aged 8 years - 17 years \& 11 months whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening For and Promotion of Health-Related Quality of Life in Children and Adolescents - a European Public Health perspective (KIDSCREEN, specifically using the KIDSCREEN 10 tool)
Global health-related quality of life measure. Minimum value 1 and maximum value 5 per question. Higher values indicate better quality of life.
Measured: 12 months
Secondary outcomes (4)
Inventory of Long COVID symptoms
Based on the ISARIC-WHO COVID-19 Survey and NICE COVID rapid evidence review
Measured: 12 months
Health service utilisation
Contacts with and attendances at GP surgery, A\&E attendance, referrals to secondary care (including paediatric fatigue clinic), hospital admission, contact with counselling / mental health services
Measured: 12 months
New medical conditions diagnosed since COVID
Any new medical conditions diagnosed since COVID (e.g. asthma, type 1 diabetes)
Measured: 12 months
School absence and attainment
Days absent and difficulties completing school work
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start19 Oct 2022
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422937
- Sponsor's protocol ID
- RG-0348-22
- Acronym
- SPLaT-19
- Status last verified
- May 2024
- First submitted
- 16 Jun 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)
- ClinicalTrials.gov ID
- NCT05422937
- Acronym / sponsor ID
- SPLaT-19 / RG-0348-22
- Conditions
- COVID-19, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 21 Jun 2022 (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.
Introduction:
While there is a substantial body of knowledge about acute Covid-19 in children and young people (CYP), less is known about long-COVID, where symptoms continue beyond four weeks, particularly since the most recent wave of the Omicron variant and the UK childhood vaccination programme roll out. This study aims to provide a picture of longer-term effects of an acute Covid-19 infection in CYP and identify their needs.
Methods and analysis:
The study comprises an observational prospective cohort study and a linked qualitative study. The cohort study will identify CYP aged 8-17 years in the West Midlands of England and, irrespective of Covid-19 status, invite them to complete an online questionnaire at point of recruitment, and after 3, 6, 9 and 12 months. CYP who have experienced long-term effects of COVID-19 will be invited to interview and, those who are currently experiencing symptoms, will be invited to record their experiences in a diary. Adults working in professional or third sector/voluntary roles with CYP will be invited to take part in a focus group to explore the perceived impact of Long-COVID on the wider experience of CYP. Approximately 900 participants will be needed for the cohort study to ensure the sample size is suitable, with approximately 20 CYP invited to interview and approximately 8 professionals invited to a focus group. Descriptive statistics will be used to describe incidence rates of symptoms and symptom resolution trajectories, and comparisons made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and development of Long-COVID at each follow-up point. Linear regression will be used to estimate associations between candidate predictors and poor outcome in terms of health-related quality of life, as described by the KIDSCREEN10. Qualitative data will be analysed thematically using the constant comparison method.
Ethics and dissemination:
Research Ethics Committee and Health Research Authority approvals will be sought. Information about where to seek support will be provided to participants to mitigate against risks of harm. Study findings will be presented at conferences and published in open access journals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and Young People aged 8-17 | – | –All CYP aged 8 years - 17 years \& 11 months whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All CYP aged 8 years - 17 years \& 11 months (inclusive), registered at a participating general practice, will be invited to participate, subject to the eligibility criteria.
Key inclusion criteria (3 listed)
- All CYP aged 8 years - 17 years \& 11 months will be eligible for the study regardless of whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported LFD OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record.
- Children and adolescents (n≈20) aged 8 to 17 years, with evidence of Long COVID, as identified through participation in SPLaT cohort and defined as symptoms persisting longer than 4 weeks following an acute episode of COVID-19.
- Adults working with children and adolescents in roles including teaching, social work, and voluntary organisations, identified by our local networks (n≈8).
Key exclusion criteria (1 listed)
- CYP aged 8-17 (inclusive) who have relevant dissent codes on their medical records, indicating that their records are not to be used for research. CYP who have declined consent for text messaging services will not be invited to the study. CYP younger than 8 years and older than 17 years and 11 months will not be invited to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening For and Promotion of Health-Related Quality of Life in Children and Adolescents - a European Public Health perspective (KIDSCREEN, specifically using the KIDSCREEN 10 tool)
Time frame: 12 months
Global health-related quality of life measure. Minimum value 1 and maximum value 5 per question. Higher values indicate better quality of life.
4 secondary outcomes
Inventory of Long COVID symptoms
Time frame: 12 months
Health service utilisation
Time frame: 12 months
New medical conditions diagnosed since COVID
Time frame: 12 months
School absence and attainment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No. Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Pediatric ALL, run by Keele University at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 22 May 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Screening For and Promotion of Health-Related Quality of Life in Children and Adolescents - a European Public Health perspective (KIDSCREEN, specifically using the KIDSCREEN 10 tool) (time frame: 12 months). 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 22 May 2024.