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)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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 CFS and PACS-CFS? (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 CFS and PACS-CFS, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Contact Information
Primary
Harald Prüß, Prof., MD
harald.pruess@charite.de
+49 30 450 560399
Backup
Hannah Preßler, MD
hannah.pressler@charite.de
+49 30 450 539778
Time Frame
Start Date:2023-10-01
Estimated Completion Date:2025-02
Participants
Target number of participants:66
Treatments
Active_comparator: Immunoadsorption
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.
Sham_comparator: Sham-apheresis
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.