G93.3
Conditions
Interventions
Group 1: Children and adolescents with Long COVID that we see regularly in our long-covid clinic. When joining our clinic we inform about our study. If they are recruited it encounters repetitive neur
Sponsors
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
Eligibility
Sex/Gender
All
Age
6 Years to 21 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria - Children age 6-21 years - written informed consent - PCR-proven SARS-CoV-2 or self-test positiv = 12 weeks ago Patient population inclusion criteria: - Diagnosis of LC with = 1 symptom and relevant impairments of daily activities (missing school e.g.) according to the WHO criteria Healthy controls inclusion criteria: - Consent to study blood drain without clinical indication for age = 14 years - if blood is drawn out of clinical indication, this can be upgraded with the study material Psychiatric disease controls: inclusion criteria: - Consent to study blood drain without clinical indication for age = 14 years - if blood is drawn out of clinical indication, this can be upgraded with the study material - depressive episode, middle to severe depression or anxiety, not in temporal connection to SARS-CoV-2-infection Postviral fatigue (non-LC) inclusion: - Consent to study blood drain without clinical indication for age = 14 years - if blood is drawn out of clinical indication, this can be upgraded with the study material
Exclusion criteria
Exclusion criteria: General exclusion criteria: - inborn errors/diseases (cerebral palsy e.g.), chronic diseases - congenital or acquired immuno deficiency - insufficient knowledge of the german language - non-consent about radiological or genetical incidental findings Patient population: exclusion criteria: - psychiatric diseases prior to LC, except for ADHD, specific learning disabilities, depression, and anxiety Healthy Controls: exclusion criteria - psychiatric diseases - medication - acute severe infection / trauma Psychiatric disease controls: exclusion criteria - other psychiatric disorders - medication without relevance to the acute psychiatric disorder - acute severe infection / trauma Postviral fatigue (non-LC): exclusion criteria: - psychiatric disorders prior to SARS-CoV-2 infection, except for ADHD, specific learning disabilities, depression, and anxiety - medication without relevance to ME/CFS - acute severe infection / trauma - non-consent about radiological oder genetical incidental findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is an observational study without intervention. Therefore we do not define primary outcomes, but Target criteria: Main Goals: 1. Build a cohort of well characterized children and adolescents (at least n=20, target n=50) with LC, suffering from impairments in their daily activity and age- and sex-matched controls (Post-COVID without residues). Build two disease control groups: psychiatric disorders and postviral Chronic fatigues syndrome without COVID. 2. Detection of possible immunologic, metabolic, genetic and radiologic signatures / biomarkers for diagnosis of LC in children and adolescents | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary target criteria: 1. Proof of viral persistence in different biomaterials 2. How is anti-body-concentration in sera correlated with saliva antibodies? Is there a difference between concentrations in antibody-subclassification? 3. Does the B-/T-cell related immun response differ in patients with LC from controls? 4. MRI: Can microstructural differences between groups be identified using MRI? Are there pathophysiological correlates of the patients’ symptoms? Can the disease control cohorts be distinguished retrospectively? 5. Metabolomics: Are there specific metabolic signatures in affected patients? Do these differ depending on the etiology? Are there metabolic changes associated with limitations in physical performance? Can a potential biomarker be developed from these signatures in conjunction with genetic factors? | — |
Countries
Germany
Contacts
Public ContactRoland Elling
Universitätsklinikum Freiburg
Outcome results
None listed