post-COVID syndrome SARS-CoV-2
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Children aged 0-17 years evaluated for post COVID syndrome at one of the participating hospitals and with a history of SARS-CoV-2 infection ( RT-PCR test or positive serology or suitable medical history)
Exclusion criteria
Exclusion criteria: -Medical history that (partially) explains the fatigue complaints or chronic fatigue syndrome related complaints in the medical history - No consent from guardians and/or patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To describe sequelae of COVID-19, primarily the PROMIS paediatric fatigue score and frequency, duration and intensity of other persisting symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| • To identify risk factors of increased fatigue (according to PROMIS paediatric fatigue) in children with post-COVID, such as gender, age, ethnicity, pre-existing diseases* • Functional testing (including spirometry, bodybox, CO-diffusion, exercise tolerance test) and imaging (chest CT-scan and ultrasound and/or MRI of the heart) * • Blood test abnormalities (kidney, liver function, thyroid function, anaemia, leucocytosis or leukopenia, thrombocytosis or thrombocythemia, increased inflammatory values of erythrocyte sedimentation rate and C-reactive protein) * • Measures of neurocognitive behavioural, school functioning (patients > 6 years) the Emma toolbox (in the Dutch cohort only) • PROMIS measures of physical, mental and social health and PedsQL • Exhaled breath profiles (Dutch cohort only) • Prevalence of olfactory dysfunction (Dutch cohort only) • Nasopharyngeal and gastro-intestinal microbiome profiles • Phenotypic and functional aspects of the innate and adaptive immune system related to the autoimmunity and antibody response against COVID-19 • Immunological profiles in children with post-COVID syndrome, compared to adults (P4O2 Covid-19 Extension study (NL74701.018.20)) • Change in PROMIS paediatric fatigue score before and after reinfection with SARS-CoV-2 • Immunological profiles in children with post-COVID syndrome, compared before and after reinfection with SARS-CoV-2 • Gene-expression profiles (transcriptomics) related to disease phenotypes and severity of post-COVID syndrome The data needed for the outcomes marked with an * will be retrieved from patient files as they are part of the normal standard of care for children with complaints of long-term fatigue. | — |
Countries
Netherlands
Outcome results
None listed