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Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS

RecruitingN/A

Sponsor: Charite University, Berlin, Germany

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), ME/CFS Following COVID-19

Interventions: IA with TheraSorb ® column (Miltenyi)

Countries: Germany

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME/CFS criteria after six months. No causal treatment exists for ME/CFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies. Immunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME/CFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME/CFS also showed symptomatic improvement in most patients. Hypothesis: Antibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME/CFS and is associated with altered memory B-cell profiles before treatment. Objective: To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response. The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients aged 18-65 years who are able to give informed consent and have: i) ME/CFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score \< 60
* Presence of autoantibodies (adrenergic or antineuronal antibodies)
* Undergoing IA with the TheraSorb® column over 5 days
* Written informed consent provided by the patient
* Health insurance coverage

Exclusion Criteria:

* Lack of willingness to store pseudonymized disease data as part of the study
* Pregnancy
* Presence of other conditions that prevent a definite ME/CFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)
* Acute infection (COVID, HIV, hepatitis)
* Severe fatigue disease with bedriddenness (Bell Disability Score \< 30)

Locations (1)

Berlin, State of Berlin, Germany