Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS

NCT05710770 | Completed

• 2 other identifiers: IA-PACS-CFS01EP2201
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ME/CFS; Post-COVID ME/CFS

Keywords

Post-COVID Syndrome; Long COVID; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 month three will be documented as indexed by the Chalder Fatigue Scale.

  3 months after completion of immunoadsorption or sham apheresis

Secondary Outcomes (14)

• Sustained improvement quantified by the Chalder Fatigue Scale

  10 days, 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis

• Verification of safety and tolerability of immunoadsorption in this patient population

  1 day, 3 months, and 6 months after completion of immunoadsorption or sham apheresis

• Improvement in severity of symptoms of chronic fatigue syndrome (CFS) as measured by the Fluge score

  1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis

• Improvement in physical function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)

  1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis

• Improvement in functional disability as measured by the Bell disability scale

  1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis

Study Arms (2)

Immunoadsorption

ACTIVE COMPARATOR

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.

Device: Immunoadsorption

Sham-apheresis

SHAM COMPARATOR

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.

Device: Immunoadsorption

Interventions

Immunoadsorption DEVICE

IA is a well-established, safe interventional therapy broadly applied for different indications. Medical complaints of the TheraSorb Ig apheresis system are rare and none led to a long-term impairment of the patient's health. In most treatments, the patients do not report any side effects. The Ig omni adsorbers specifically remove antibodies. Other components of the blood, except for an unspecific loss of plasma during the treatment, are not removed. Main adverse effects can occur due to the necessity of a Shaldon catheter and include accidental puncture of carotid artery. The procedure is performed under sonographic control and a chest-x-ray is performed afterwards to ensure integrity of lungs.

Immunoadsorption; Sham-apheresis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (5)

• Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

  PMID: 32644129 BACKGROUND

• Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.

  PMID: 34308300 BACKGROUND

• Scheibenbogen C, Loebel M, Freitag H, Krueger A, Bauer S, Antelmann M, Doehner W, Scherbakov N, Heidecke H, Reinke P, Volk HD, Grabowski P. Immunoadsorption to remove ss2 adrenergic receptor antibodies in Chronic Fatigue Syndrome CFS/ME. PLoS One. 2018 Mar 15;13(3):e0193672. doi: 10.1371/journal.pone.0193672. eCollection 2018.

  PMID: 29543914 BACKGROUND

• Tolle M, Freitag H, Antelmann M, Hartwig J, Schuchardt M, van der Giet M, Eckardt KU, Grabowski P, Scheibenbogen C. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Efficacy of Repeat Immunoadsorption. J Clin Med. 2020 Jul 30;9(8):2443. doi: 10.3390/jcm9082443.

  PMID: 32751659 BACKGROUND

• Pressler H, Machule ML, Ufer F, Bunger I, Li LY, Buchholz E, Werner C, Beraha E, Wagner F, Metz M, Burock S, Bruckert L, Franke C, Wilck N, Kruger A, Reshetnik A, Eckardt KU, Endres M, Pruss H. IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS). Trials. 2024 Mar 7;25(1):172. doi: 10.1186/s13063-024-07982-5.

  PMID: 38454468 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Harald Prüß, Prof., MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Experimental Neurology

Model Details: Double-blinded, randomized, sham-controlled trial

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 2, 2023
• Study Start: October 1, 2023
• Primary Completion: August 4, 2025
• Study Completion: October 8, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-04

Locations

DE (1)