NCT05710770Completed
Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS
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)
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 31 Jan 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 4 Aug 2025
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05710770
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 1 Oct 2023 to the primary completion date, 4 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current indispensable medication with ACE inhibitors
- Ongoing immunosuppressive therapy
Other illness
- Acute or severe psychiatric disease
- Presence of other conditions or differential diagnosis better explaining the symptoms of the patient than the suspected ME/CFS
- Active/acute infectious diseases like TBC, HIV, CMV, EBV, HBV, HBC
Lab values
- 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
Age
- Fatigue duration for ≥5 years
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.