Randomized-controlled Trial of Immunoadsorption (IA) in Patients With Chronic Fatigue Syndrome (CFS) Including Patients With Post-COVID-19 CFS (PACS-CFS)

The goal of this clinical trial is to learn about the effectiveness of repeated immunoadsorption intervention in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS).The main questions it aims to answer are: (1) Does repeated immunoadsorption relieve fatigue and/or other symptoms associated with CSF and PACS-CSF? (2) Is repeated immunoadsorption safe and tolerable in this patient population? What are the side effects of repeated immunoadsorption, and how common are they?Participants will be asked to participate for approx. 32 weeks (8 months). After screening, participants will receive assigned intervention of either five immunoadsorption treatments (with Ig adsorber) every other day over 10 days or matching sham treatments (without Ig adsorber), followed by a 6-month follow-up period with three ambulatory visits. Every participant will undergo trial outcome, safety, and monitoring assessments.The results of this study will provide information on whether repeated immunoadsorption can alleviate symptoms associated with CSF and PACS-CSF, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.

Inclusion Criteria:Subjects of all genders ≥18 <65 years at time of informed consentDiagnosed ME/CFS according to CCC 2003 including patients with PACS-CFS at screening with Bell Score ≥20 and ≤50Detection of at least one kind of autoantibodies measured during screening (among others antineuronal-, ß2-adrenergic-receptor-, muscarine-receptorantibodies) in serum or CSFExclusion Criteria:Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others:malignant disease within the last 5 yearsclinically meaningful laboratory abnormalitiesmoderate to severe renal insufficiencycardiac insufficiency with an LVEF lower than 40%, uncontrolled cardiac arrhythmia, severe coronary heart diseasesevere HypercoagulabilityAcute or severe psychiatric diseaseCurrent indispensable medication with ACE inhibitorsFatigue duration for ≥5 yearsPresence of other conditions or differential diagnosis better explaining the symptoms of the patient than the suspected ME/CFSOngoing immunosuppressive therapyActive/acute infectious diseases like TBC, HIV, CMV, EBV, HBV, HBC