Immunoadsorption for autoantibody-positive post-infectious ME/CFS
Official title: Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Run by Charite University, Berlin, Germany · NCT07529197 · Data updated 2026-11-12
This study will try immunoadsorption (a blood-filtering procedure) to remove autoantibodies in adults with infection-triggered ME/CFS, including cases after COVID, who have detectable antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07529197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with ME/CFS by the Canadian Consensus Criteria, post-infectious onset (including post-COVID), significant functional impairment (Bell <60), detectable adrenergic or antineuronal autoantibodies, health insurance, and willingness to undergo IA and follow-up are ideal candidates.
✕Probably not a fit
Patients without detectable autoantibodies, with alternative diagnoses that preclude ME/CFS, acute infections, pregnancy, severe comorbidities, or very severe bedridden fatigue (Bell <30) are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort of adults with ME/CFS meeting the Canadian Consensus Criteria who have detectable adrenergic or antineuronal autoantibodies and are treated with immunoadsorption (IA) as routine care. IA is performed using TheraSorb® columns over five outpatient sessions on days 1, 2, 4, 6, and 8 at Diamedikum Potsdam, independent of study participation. Baseline labs, autoantibody measures, symptom questionnaires (SF-36 PF, Chalder Fatigue, Bell Disability Scale, weighted CCC score), and functional tests (handgrip, NASA Lean Test) are collected, with blood sampling and further assessments at 2 and 6 months and monthly questionnaires for 12 months. Data are collected prospectively to describe clinical course and symptom changes after IA in this autoantibody-positive ME/CFS population.
Why it matters
Potential benefit: If successful, immunoadsorption could reduce fatigue and improve physical function and daily activities for autoantibody-positive ME/CFS patients.
How similar studies have gone: Earlier proof-of-concept IA reports in infection-related ME/CFS (2018, 2020) and a 2024 publication from the same group reported symptomatic improvement in many patients.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany Recruiting
Study contacts
- Principal investigator: Carmen Scheibenbogen, Prof. Dr. — Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,
- Study coordinator: Elisa A Stein, Dr.
- Email: elisa.stein@charite.de
- Phone: +49 450 624354
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.