Non-hospitalised Children & young people (CYP) with Long Covid (The CLoCk Study)
Lead Research Organisation:
Great Ormond Street Hospital
Department Name: UNLISTED
Abstract
a. aim(s) of the research: It seems that some children and young people (CYP) remain ill for a long time after infection with COVID virus. They are said to have ‘long COVID’. Something similar can follow a common childhood infection called glandular fever. Doctors don’t know how to diagnose long COVID, how common it is or how long it goes on for. There is no simple test for long COVID. We need to know more about it if we want to treat it. b. background to the research: Little is known about long COVID in adults or CYP. Risk factors for worse COVID in CYP include obesity, pre-existing diseases, learning disabilities, diseases of the brain, mental health problems and coming from an ethnic minority. The CYP likely to be most at risk of long COVID are teenagers who are more at risk of persistent fatigue and mental health problems after other viral infections. c. design and methods used: We will approach 30,000 CYP, half of whom we know had COVID. We expect 6,000 to agree to help us and we will ask them whether they still have physical or mental problems at 3, 6,12 and 24 months afterwards. We can compare the 3,000 responders who had a positive COVID test with the 3,000 responders who didn’t test positive. We can then agree on what is a medical diagnosis of long COVID and how we might treat it. d. patient and public involvement: (PPI): We will have a paid PPI lead who will ensure co-production with carers and CYP. We will also use some funds to encourage busy carers and CYP to give their valuable time to complete the survey s.e. Complete transparency: We will share all our results ASAP for free with anyone who wants to see them, especially the CYP who take part.
Technical Summary
This COVID-19 Long COVID award is jointly funded (50:50) between UKRI/Medical Research Council and the National Institute for Health Research. The figure displayed is the UKRI/MRC amount only, each partner is contributing equally towards the project so the Total Fund Amount is £1,869,949.
Uncertainties relate to diagnosis, prevalence, duration and treatment of post-COVID syndrome (‘long COVID’) in children and young people (CYP). There is no diagnostic test nor definition for long COVID. We do not know the physical, psychological and social consequences of long COVID and we need to define the clinical phenotype and longer-term physical/physiological/psychological changes to target therapeutic interventions. Risk factors for acute COVID include: obesity, pre-existing co-morbidities, learning and neurological disabilities, mental health(MH) problems, BAME status. The CYP likely to be most at risk of long COVID are teenagers as they represent the majority of CYP pre-COVID with persistent physical and MH symptoms post-viral infection. Ludwigsson (2020) reported five COVID positive CYP with median age 12 yrs with symptoms longer than 6 months. The research questions: 1. To describe the clinical phenotype of post-COVID symptomatology in test-positive CYP, using test-negative comparators 2. Use these data to produce an operational definition of long COVID, necessary for any future epidemiological or interventional study 3. Use this definition to establish the prevalence and natural course of long COVID in CYP to inform NHS services and health policy HYPOTHESIS: the type, prevalence and trajectory of symptoms in COVID positive CYP will differ significantly from the comparator group, allowing us to construct an operational definition of long COVID. We plan a longitudinal cohort study of non-hospitalised CYP aged 11-17 yrs. We will approach 30,000 CYP, half of whom with proven COVID. We expect 6,000 to consent to help us. We will ask them whether they still have physical or mental health problems at 3, 6,12 and 24 months afterwards. The 3,000 CYP with a positive SARS-CoV-2 tests will be compared with 3,000 test-negative controls. DELIVERABLES: we will access large numbers with proven COVID quickly to generate early outputs to inform future intervention studies and health policy.
Uncertainties relate to diagnosis, prevalence, duration and treatment of post-COVID syndrome (‘long COVID’) in children and young people (CYP). There is no diagnostic test nor definition for long COVID. We do not know the physical, psychological and social consequences of long COVID and we need to define the clinical phenotype and longer-term physical/physiological/psychological changes to target therapeutic interventions. Risk factors for acute COVID include: obesity, pre-existing co-morbidities, learning and neurological disabilities, mental health(MH) problems, BAME status. The CYP likely to be most at risk of long COVID are teenagers as they represent the majority of CYP pre-COVID with persistent physical and MH symptoms post-viral infection. Ludwigsson (2020) reported five COVID positive CYP with median age 12 yrs with symptoms longer than 6 months. The research questions: 1. To describe the clinical phenotype of post-COVID symptomatology in test-positive CYP, using test-negative comparators 2. Use these data to produce an operational definition of long COVID, necessary for any future epidemiological or interventional study 3. Use this definition to establish the prevalence and natural course of long COVID in CYP to inform NHS services and health policy HYPOTHESIS: the type, prevalence and trajectory of symptoms in COVID positive CYP will differ significantly from the comparator group, allowing us to construct an operational definition of long COVID. We plan a longitudinal cohort study of non-hospitalised CYP aged 11-17 yrs. We will approach 30,000 CYP, half of whom with proven COVID. We expect 6,000 to consent to help us. We will ask them whether they still have physical or mental health problems at 3, 6,12 and 24 months afterwards. The 3,000 CYP with a positive SARS-CoV-2 tests will be compared with 3,000 test-negative controls. DELIVERABLES: we will access large numbers with proven COVID quickly to generate early outputs to inform future intervention studies and health policy.
