Molecular immunological characterisation and multi-centric patient-centered care of children and adolescents with Long COVID in Baden-Württemberg

Recruiting

• Conditions: G93.3; Postviral fatigue syndrome

• Registration Number: DRKS00033269
• Lead Sponsor: niversitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

General inclusion criteria
- Children age 6-18 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

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

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
- medication without relevance to ME/CFS
- acute severe infection / trauma
- non-consent about radiological oder genetical incidental findings

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is an observational study without intervention. Therefore we do not define primary outcomes, but Target criteria: <br>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. <br>2. Detection of possible immunologic, metabolic, genetic and radiologic signatures / biomarkers for diagnosis of LC in children and adolescents

Secondary Outcome Measures

Name	Time	Method
Secondary target criteria: <br>1. Proof of viral persistence in different biomaterials<br>2. How is anti-body-concentration in sera correlated with saliva antibodies? Is there a difference between concentrations in antibody-subclassification? <br>3. Does the B-/T-cell related immun response differ in patients with LC from controls?