Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS
ME/CFS, Post-COVID ME/CFS
About this trial
This is an interventional treatment trial for ME/CFS focused on measuring Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
Eligibility 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
Sites / Locations
- Charité - Universitätsmedizin BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Immunoadsorption
Sham-apheresis
Immunoadsorption will be conducted with the TheraSorb LIFE 21 apheresis system in combination with the TheraSorb-Ig omni 5 adsorber over a period of 9-12 days: each participant will receive five immunoadsorption cycles treating 2.0 - 2.5 patient's plasma volumes every other day. Initial pilot studies have demonstrated this dose finding to be effective and well tolerated (Scheibenbogen et al., 2018; Tolle et al., 2020). The immunoapheresis material will be provided by the Miltenyi company at the beginning of the study. Concerning the high effectiveness of immunoadsorption therapy in patients with other neuroimmunological diseases and the invasiveness of a sham-apheresis, a 2:1 randomization was chosen in order to ensure that more patients will receive a verum IA treatment.
To have identical conditions to the immunoadsorption, sham apheresis will also be conducted with the TheraSorb LIFE 21 apheresis system over a period of 9-12 days: each participant will receive five sham cycles. For the sham apheresis, a TheraSorb LIFE 21 unit with blocked Ig adsorbers and without regeneration of the adsorbers during the treatment will be used, ensuring that the patient and the investigator are blinded. The study nurses applying the treatment (a specific person only in charge of the patient during the treatment) cannot be blinded.