Immunoadsorption treatment for chronic fatigue syndrome and post-COVID fatigue
Double-blinded, Randomized, Sham-controlled Trial of Immunoadsorption (IA) in Patients With Chronic Fatigue Syndrome (CFS) Including Patients With Post-acute COVID-19 CFS (PACS-CFS)
This study is testing if a new treatment called immunoadsorption can help people with chronic fatigue syndrome and post-COVID fatigue feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05710770 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of repeated immunoadsorption interventions in patients suffering from chronic fatigue syndrome (CFS), including those with post-acute COVID-19 syndrome (PACS-CFS). Participants will be randomly assigned to receive either the immunoadsorption treatment or a sham treatment over a period of 10 days, followed by a 6-month follow-up. The primary goal is to assess clinical improvement in fatigue and other symptoms using the Chalder Fatigue Scale. The study also aims to evaluate the safety and tolerability of the treatment in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with ME/CFS or PACS-CFS, who have detectable autoantibodies.
Not a fit: Patients with severe comorbidities, acute psychiatric conditions, or those who have experienced fatigue for five years or more may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate fatigue and improve the quality of life for patients with chronic fatigue syndrome and post-COVID fatigue.
How similar studies have performed: While there is growing interest in immunoadsorption for autoimmune conditions, this specific approach for CFS and PACS-CFS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects of all genders ≥18 \<65 years at time of informed consent * Diagnosed ME/CFS according to Canadian consensus criteria (CCC) 2003 including patients with PACS-CFS at screening with Bell Score ≥20 and ≤50 * Detection of at least one kind of autoantibodies measured during screening (among others antineuronal-, ß2-adrenergic-receptor-, muscarine-receptorantibodies) in serum or CSF Exclusion Criteria: * Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others: * malignant disease within the last 5 years * clinically meaningful laboratory abnormalities * moderate to severe renal insufficiency * cardiac insufficiency with an LVEF lower than 40%, uncontrolled cardiac arrhythmia, severe coronary heart disease * severe Hypercoagulability * Acute or severe psychiatric disease * Current indispensable medication with ACE inhibitors * Fatigue duration for ≥5 years * Presence of other conditions or differential diagnosis better explaining the symptoms of the patient than the suspected ME/CFS * Ongoing immunosuppressive therapy * Active/acute infectious diseases like TBC, HIV, CMV, EBV, HBV, HBC
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Harald Prüß, Prof., MD — Charite University, Berlin, Germany
- Study coordinator: Harald Prüß, Prof., MD
- Email: harald.pruess@charite.de
- Phone: +49 30 450 560399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.