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Observational Study of the Effect of Immunoadsorption (IA) in Patients < 18 Years of Age with ME/CFS with Evidence of Autoantibodies (BIAKI)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2023-10-31
Completion (planned):
2025-11-29
Last update:
2023-11-30

 

Research types:
Clinical research
Research areas:
Immunological dysfunction
Interventions:
TheraSorb®, Immunoadsorption
Priv. Sector Partner:
Sponsors:

Project description

Chronic fatigue syndrome ME/CFS is a complex neurological systemic disease. This systemic disease, which has also been described after other infections, is considered one of the most severe and complex manifestations of the post-COVID syndrome (PCS) (Renz-Poster & Scheibenbogen 2022). The clinical picture is characterized by persistent severe fatigue with the core symptom of postexertional malaise (PEM), an exercise intolerance with an increase in symptoms after exertion that lasts at least until the next day (> 14h). Other symptoms include headache, muscle pain, cognitive impairment (brain fog), autonomic dysfunction such as orthostatic intolerance, sleep disturbances, and a severe feeling of illness. After mild to moderate outpatient COVID infection, approximately 15% of adults develop PCS with fatigue, exercise intolerance, cognitive impairment, headache, muscle pain, and many other symptoms (Chen et al. 2022, Kedor et al. 2022). At least half of adult PCS cases persist for more than 12 months, and about 20% progress with severe limitations in daily living (Han et al. 2022).

Much less is known about the prevalence of post-covid syndrome in children and adolescents than in adults. The prognosis of the disease is unfavorable, especially for the severely and very severely affected patients (Sommerfelt et al 2023). One of the pathomechanisms described by several research groups is autoimmunity. It has been shown that SARS-CoV-2 infection can trigger autoantibodies that correlate with symptom severity (Cabral-Marques et al. 2022). There is currently no proven therapy for this severe disease. There have been numerous therapeutic attempts using immunoadsorption in adults. One such therapeutic approach for autoantibodies is immunoadsorption (IA), a form of apheresis or "blood washing" in which antibodies are removed from the blood. IA is common practice for several antibody-mediated autoimmune diseases with overall low risk (Hamilton et al. 2019). Documentation of potential improvements in symptoms and affectedness in children and adolescents (12-18 years) with PCS by antibody depletion using IA has not been done to date. Therefore, the present project aims to conduct an observational study as a pre-post comparative study in routine clinical care that may provide initial evidence of potential efficacy and may further lay the foundation for a randomized intervention trial (RCT).

Study participants will be recruited from a group of pediatric patients who are scheduled for immunoadsorption due to ME/CFS.

The primary study objective is to compare physical functioning over 12 months after IA (via monthly surveys) with physical functioning prior to IA, with the main comparison 2 weeks before IA and 3 months after IA, measued by the SF 36- Physical Function (PF) Questionnaire (continuous score).

(Description adapted from clinical trial website: see link above)

Patient cohort

ME/CFS according to Canadian Consensus Criteria (CCC), adapted for children. Detection of autoantibodies (adrenergic, ANA, antineuronal, G protein-coupled receptors (GPCR) or others).

Patients enrolled: 30

Age group: 12 - 18 years (Children, Adults)

Research areas (4)
Research types (1)
Research networks (0)
Working groups (0)
People (1)
Publications (0)
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Research areas

Immunological dysfunction
Description:
Immune system is the body's defense mechanism against foreign organisms or substances and deviant native cells. It includes the humoral immune response and the cell-mediated response and consists of a complex of interrelated cellular, molecular, and genetic components. Diseases of the immune system are disorders caused by abnormal or absent immunologic mechanisms, whether humoral, cell-m...
Research projects:
17
Publications:
39