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

Recruitingn/aAges 18 Years - 65 YearsAllCharite University, Berlin, Germany
NCT07529197 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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)
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What it tests

  • IA with TheraSorb ® column (Miltenyi)
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Where

1 site
Charité - Universitätsmedizin Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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