Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS
IMPACT
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2026
CompletedFirst Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 14, 2026
April 1, 2026
1.3 years
March 31, 2026
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 is an established and widely used health-related quality of life measure. The PF domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
8 weeks after first IA
Secondary Outcomes (8)
Improvement in ability to work in daily hours
before first IA; 3 and 6 months after last IA
Improvement in hand grip strength
8 weeks after first IA
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score
8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)
8 weeks after first IA; 3 and 6 months after last IA
- +3 more secondary outcomes
Interventions
IA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice.
Eligibility Criteria
Patients presenting to our outpatient clinic who meet the CCC for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC criteria are also eligible for IA and study inclusion.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
Related Publications (6)
Tölle M, Freitag H, Antelmann M, Hartwig J, Schuchardt M, van der Giet M, Eckardt KU, Grabowski P, Scheibenbogen C. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Efficacy of Repeat Immunoadsorption. J Clin Med. 9(8):2443, 2020
BACKGROUNDScheibenbogen C, Loebel M, Freitag H, Krueger A, Bauer S, Antelmann M, Doehner W, Scherbakov N, Heidecke H, Reinke P, Volk HD, Grabowski P. Immunoadsorption to remove ß2 adrenergic receptor antibodies in Chronic Fatigue Syndrome CFS/ME. PLoS One. e0193672; 2018
BACKGROUNDStein E, Heindrich C, Wittke K, Kedor C, Rust R, Freitag H, Sotzny F, Krüger A, Tölle M, Grabowski P, Scheibenbogen C, Kim L. Efficacy of repeated immunoadsorption in patients with post-COVID myalgic encephalomyelitis/chronic fatigue syndrome and elevated β2-adrenergic receptor autoantibodies: a prospective cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101161.
BACKGROUNDSotzny F, Filgueiras IS, Kedor C, Freitag H, Wittke K, Bauer S, et al. Dysregulated autoantibodies targeting vaso- and immunoregulatory receptors in Post COVID Syndrome correlate with symptom severity. Front Immunol. 2022;13:981532.
BACKGROUNDKedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID- 19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022;13:5104.
BACKGROUNDScheibenbogen C, Kedor C, Behrends U. ME/CFS, Der niedergelassene Arzt, 12/2020
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Scheibenbogen, Prof. Dr.
Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Institute for Medical Immunology (Prof. Dr. med.)
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 14, 2026
Study Start
March 11, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04