ME/CFSNCT05710770
Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS
A study testing Immunoadsorption in people with ME/CFS and Post-COVID ME/CFS, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ME/CFS, Post-COVID ME/CFS
- What is being tested?
- Immunoadsorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2023to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: 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)
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?
Read more
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.
Read the detailed description
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition with a varying prevalence of 0.3 - 3% and markedly restricts activity and function of patients. They experience severe fatigue even after minimal exercise or mental activity, together with a myriad of further symptoms such as cognitive impairment, poor sleep quality, muscle and joint pain, or headache. With the pandemic situation, ME/CFS related to post-acute COVID-19 syndrome (PACS) is becoming a raising issue. According to the WHO (in February 2022), there are more than 423 million confirmed cases of COVID-19 worldwide and a large proportion of patients discharged from hospital are suffering from persistent symptoms (Carfi et al., 2020; Davis et al., 2020).
The etiology and the mechanisms leading to the typical chronic course of ME/CFS or the pathophysiology of PACS are not fully understood. There is increasing evidence that a post-viral autoimmune reaction with the presence of autoantibodies targeting different neuronal tissues is involved in the pathogenesis.
This is a double-blinded, randomized, sham-controlled immunoadsorption (IA) study in patients with chronic fatigue syndrome (CFS) including patients with CFS related to post-acute COVID-19 syndrome (PACS-CFS). Primary endpoint of the study is clinical improvement 3 months after the completion of immunoadsorption (IA) quantified using the change from baseline of the Chalder Fatigue Scale (range 0-33). Patients are randomized 2:1 in order to provide therapy to as many patients as possible. During the screening period, all patients are tested for the presence of autoantibodies in blood and cerebrospinal fluid (CFS). A comprehensive characterization by CFS specific questionnaires, quality of life questionnaires (PROMIS), cognitive and neuropsychological testing (MOCA, CANTAB) is performed, and each patient is offered to receive an optional cranial MRI before and after immunoadsorption. Depending on the clinical phenotype, electromyography and pulmonary function testing will be done. We use established hand strength and finger tapping devices as well as an accelerometer to objectify clinical improvement. Patients are hospitalized for 9-12 days receiving IA 5 times every other day. Directly after completion of IA as well as at month 1, 3 and 6 there are followup visits.
The study will help to better understand disease mechanisms and thereby allow (hopefully biomarker associated) characterization of patients benefitting from such a costly but safe and often highly efficient therapy.
- Conditions
- ME/CFS, Post-COVID ME/CFS
- Being tested
- Immunoadsorption
- Keywords
- Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoadsorptionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Immunoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after completion of immunoadsorption or sham apheresis
Secondary outcomes (14)
Sustained improvement quantified by the Chalder Fatigue Scale
Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented.
Measured: 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
Number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs
Measured: 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
The Fluge score uses a visual analogue scale ranging from 1 to 10 (1 = no symptom, 10 = very severe symptom) to assess 32 self-reported CFS symptoms including fatigue, pain, cognitive, and other CFS-related symptoms. Intra-patient change in Fluge score from baseline to follow-up points will be documented.
Measured: 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)
The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change in SF-36-PF from baseline to follow-up points will be documented.
Measured: 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
The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change in Bell score from baseline to follow-up points will be documented.
Measured: 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis
Improvement in fatigue quantified by post exertional malaise (PEM) questionnaire
The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. Intra-patient change in PEM score from baseline to follow-up points will be documented.
Measured: 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis
Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)
Intra-patient change in hand grip strength (HGS) from baseline to follow-up points.
Measured: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)
The Composite Autonomic Symptom Score (COMPASS-31) is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). Intra-patient change in autonomic dysfunction from baseline to follow-up points will be documented as indexed by the COMPASS-31.
Measured: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in symptoms of autonomic dysfunction by measuring blood pressure and heart rate regulation with the Schellong Test
The Schellong Test is a test for circulatory function. The patient is required to stand for 10 to 20 min, during which time the blood pressure is measured continuously. A fall of systolic pressure of 20 mm Hg or more indicates poor circulatory function. Intra-patient change in Schellong Test from baseline to follow-up points will be documented.
Measured: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in neurocognitive functions as measured by the Montreal Cognitive Assessment (MoCA)
MoCA is a sensitive and validated cognitive screening tool to test subjects quickly and accurately for mild cognitive impairment, irrespective of etiology. A person can gain a maximum of 30 points, and professionals consider a score of 26 or above to be normal. A score of 25 points or less may indicate some degree of cognitive impairment (18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment, fewer than 10 points = severe cognitive impairment). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.
Measured: 3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis
Improvement in neurocognitive functions as measured by the symbol digit modalities test (SDMT)
The SDMT (oral version) detects cognitive impairment in less than five minutes and will be used to assess change in cognitive function over time. SDMT is a validated and established measure of cognition in multiple sclerosis capturing impairments such as processing speed and working memory, visual search and scanning and oculomotor functioning. Patients are provided a sheet with nine symbols, each paired with a number on top of the page. The remainder of the page consists of a randomized, sequential assortment of these symbols. Participants are asked to verbally respond with the number that corresponds with each symbol. The final score is the correct number of substitutions in 90 s (range 0 to 110, higher score = higher neurocognitive function). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.
Measured: 3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis
Improvement in quality of life (QoL) as measured by the PROMIS questionnaire
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures can be used with the general population and with individuals living with chronic conditions. Intra-patient change in PROMIS score from baseline to follow-up points will be documented.
Measured: 3 months and optional 6 months after completion of immunoadsorption or sham apheresis
Changes in biomarkers of autoimmune activity
Intra-patient changes in biomarkers of autoimmune activity (autoantibody titers against neurotransmitter receptors; among others ß2-adeno-receptor- and muscarine- receptor-antibodies) in blood and optional in cerebrospinal fluid at month 3 after IA completion compared to baseline.
Measured: 3 months after completion of immunoadsorption or sham apheresis
Changes in biomarkers of inflammation
Intra-patient change in biomarkers of inflammation (CRP, ferritin, MBL, white blood cell count, complement factors, cytokines, immunoglobulin level and subtype) in blood at month 3 and 6 after IA completion compared to baseline.
Measured: 3 months and 6 months after completion of immunoadsorption or sham apheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Oct 2023
- Primary completion4 Aug 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ME/CFSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, sham-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Pruess, Charite University, Berlin, Germany
- Investigators
- Harald Prüß, Prof., MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710770
- Sponsor's protocol ID
- IA-PACS-CFS
- Other IDs
- 01EP2201
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32644129Davis 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.
PubMed 34308300Scheibenbogen 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.
PubMed 29543914Tolle 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.
PubMed 32751659Pressler 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.
PubMed 38454468
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05710770
- Acronym / sponsor ID
- IA-PACS-CFS
- Conditions
- ME/CFS, Post-COVID ME/CFS
- Keywords
- Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition with a varying prevalence of 0.3 - 3% and markedly restricts activity and function of patients. They experience severe fatigue even after minimal exercise or mental activity, together with a myriad of further symptoms such as cognitive impairment, poor sleep quality, muscle and joint pain, or headache. With the pandemic situation, ME/CFS related to post-acute COVID-19 syndrome (PACS) is becoming a raising issue. According to the WHO (in February 2022), there are more than 423 million confirmed cases of COVID-19 worldwide and a large proportion of patients discharged from hospital are suffering from persistent symptoms (Carfi et al., 2020; Davis et al., 2020).
The etiology and the mechanisms leading to the typical chronic course of ME/CFS or the pathophysiology of PACS are not fully understood. There is increasing evidence that a post-viral autoimmune reaction with the presence of autoantibodies targeting different neuronal tissues is involved in the pathogenesis.
This is a double-blinded, randomized, sham-controlled immunoadsorption (IA) study in patients with chronic fatigue syndrome (CFS) including patients with CFS related to post-acute COVID-19 syndrome (PACS-CFS). Primary endpoint of the study is clinical improvement 3 months after the completion of immunoadsorption (IA) quantified using the change from baseline of the Chalder Fatigue Scale (range 0-33). Patients are randomized 2:1 in order to provide therapy to as many patients as possible. During the screening period, all patients are tested for the presence of autoantibodies in blood and cerebrospinal fluid (CFS). A comprehensive characterization by CFS specific questionnaires, quality of life questionnaires (PROMIS), cognitive and neuropsychological testing (MOCA, CANTAB) is performed, and each patient is offered to receive an optional cranial MRI before and after immunoadsorption. Depending on the clinical phenotype, electromyography and pulmonary function testing will be done. We use established hand strength and finger tapping devices as well as an accelerometer to objectify clinical improvement. Patients are hospitalized for 9-12 days receiving IA 5 times every other day. Directly after completion of IA as well as at month 1, 3 and 6 there are followup visits.
The study will help to better understand disease mechanisms and thereby allow (hopefully biomarker associated) characterization of patients benefitting from such a costly but safe and often highly efficient therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomized, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | Active comparator | Device: ImmunoadsorptionImmunoadsorption 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-apheresis | Sham comparator | Device: ImmunoadsorptionTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunoadsorptionIA 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. | Device | Immunoadsorption, Sham-apheresis |
Primary outcome
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
Time frame: 3 months after completion of immunoadsorption or sham apheresis
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.
14 secondary outcomes
Sustained improvement quantified by the Chalder Fatigue Scale
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis
Improvement in fatigue quantified by post exertional malaise (PEM) questionnaire
Time frame: 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis
Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)
Time frame: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)
Time frame: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in symptoms of autonomic dysfunction by measuring blood pressure and heart rate regulation with the Schellong Test
Time frame: 10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis
Improvement in neurocognitive functions as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: 3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis
Improvement in neurocognitive functions as measured by the symbol digit modalities test (SDMT)
Time frame: 3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis
Improvement in quality of life (QoL) as measured by the PROMIS questionnaire
Time frame: 3 months and optional 6 months after completion of immunoadsorption or sham apheresis
Changes in biomarkers of autoimmune activity
Time frame: 3 months after completion of immunoadsorption or sham apheresis
Changes in biomarkers of inflammation
Time frame: 3 months and 6 months after completion of immunoadsorption or sham apheresis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 32644129Carfi 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.
- Background: PubMed 34308300Davis 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.
- Background: PubMed 29543914Scheibenbogen 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.
- Background: PubMed 32751659Tolle 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.
- Derived from this study: PubMed 38454468Pressler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Prüß, Prof., MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoadsorption in people with ME/CFS and Post-COVID ME/CFS, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale (time frame: 3 months after completion of immunoadsorption or sham apheresis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710770, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.