Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)

COVID-19 Clinical Trial

— SPLaT-19  

Official title:

Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05422937
• Other study ID #: RG-0348-22
• Status: Active, not recruiting
• Start date: October 19, 2022
• Est. completion date: May 6, 2024

Study information

• Verified date: July 2023
• Source: Keele University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 502
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria for Cohort:

• 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.

Exclusion Criteria for Cohort:

• 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.

Inclusion Criteria for Interviews:

• 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.

Inclusion Criteria for Focus Group:

• Adults working with children and adolescents in roles including teaching, social work, and voluntary organisations, identified by our local networks (n˜8).

Related Conditions & MeSH terms

• COVID-19
• Pediatric ALL

Locations

Country	Name	City	State
United Kingdom	Keele University	Newcastle Under Lyme	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
Keele University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Inventory of Long COVID symptoms	Based on the ISARIC-WHO COVID-19 Survey and NICE COVID rapid evidence review	12 months
Secondary	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	12 months
Secondary	New medical conditions diagnosed since COVID	Any new medical conditions diagnosed since COVID (e.g. asthma, type 1 diabetes)	12 months
Secondary	School absence and attainment	Days absent and difficulties completing school work	12 months