Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCharite University, Berlin, Germany
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IA with TheraSorb ® column (Miltenyi)
DeviceIA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
8 weeks after first IASecondary outcomes
1
Improvement in ability to work in daily hours
Number of patients with an intra-patient change in his/her/their ability to work in daily hours from 6 months before first IA to 12 months after last IA.
Time frame
before first IA; 3 and 6 months after last IA2
Improvement in hand grip strength
Intra-patient change in hand grip strength from baseline to follow-up points assessed using the Handgrip-Muscle-Fatigue Test.
Time frame
8 weeks after first IA3
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
The Chalder Fatigue Scale measures the extent and severity of tiredness and has been used in multiple randomized trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is answered on a 4-point scale with an overall score ranging from 0 (asymptomatic) to 33 (maximum symptomology). Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented as indexed by the Chalder Fatigue Scale.
Time frame
8 weeks after first IA; 3 and 6 months after last IA4
Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score
The CCC Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). Intra-patient change in ME/CFS symptoms from baseline to follow-up points will be documented as indexed by the CCC Symptom Score.
Time frame
8 weeks after first IA; 3 and 6 months after last IASponsors and contacts
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
German Federal Ministry of Research, Technology, and Space (BMFTR)
Collaborator
Weidenhammer-Zöbele Foundation
Collaborator
Source ClinicalTrials.gov