Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)IMPACTNCT07529197
Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS
An observational study of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and ME/CFS Following COVID-19, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), ME/CFS Following COVID-19
- What is being tested?
- IA with TheraSorb ® column (Miltenyi)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients presenting to our outpatient clinic who meet the CCC for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC criteria are also eligible for IA and study inclusion.
Who may be able to join
- Patients aged 18-65 years who are able to give informed consent and have: i) ME/CFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score < 60
- Presence of autoantibodies (adrenergic or antineuronal antibodies)
- Undergoing IA with the TheraSorb® column over 5 days
- Written informed consent provided by the patient
- Health insurance coverage
Who cannot join
- Lack of willingness to store pseudonymized disease data as part of the study
- Pregnancy
- Presence of other conditions that prevent a definite ME/CFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)
- Acute infection (COVID, HIV, hepatitis)
- Severe fatigue disease with bedriddenness (Bell Disability Score < 30)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Carmen Scheibenbogen, Prof. Dr., +49 30 450 524103, carmen.scheibenbogen@charite.de
About this study
Official title: Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME/CFS criteria after six months. No causal treatment exists for ME/CFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies.
Immunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME/CFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME/CFS also showed symptomatic improvement in most patients.
Read more
Hypothesis:
Antibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME/CFS and is associated with altered memory B-cell profiles before treatment.
Objective:
To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.
The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.
Read the detailed description
Patients presenting to our outpatient clinic who meet the Canadian Consensus Criteria (CCC) for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC are also eligible for IA and study inclusion.
IA is performed independently of the study at the Diamedikum Potsdam. The standard clinical schedule includes five outpatient sessions on days 1, 2, 4, 6, and 8. This procedure follows routine clinical practice and is not influenced by study participation.
At study inclusion, all patients undergo baseline assessments including routine laboratory tests, immunoglobulins, autoantibodies, and biomarkers, with a total of 50 ml of blood collected. Additional diagnostic workup is performed as clinically indicated. The diagnosis of ME/CFS is confirmed using the CCC.
Health status and symptom severity are documented using validated questionnaires: SF-36 (Physical Function subscale), work ability (past 12 months), weighted CCC symptom score, Chalder Fatigue Questionnaire, and Bell Disability Scale. These are completed monthly for 12 months after treatment. To reduce participant burden, questionnaires are mailed to patients for home completion.
Further clinical and laboratory assessments are conducted before IA and at 2- and 6-months post-treatment: i) Handgrip strength, ii) NASA Lean Test, and iii) Blood sampling.
The total study duration per participant is 12 months after IA.
This is a non-interventional observational study following patients with ME/CFS or PCS undergoing IA using the TheraSorb® Immunoadsorption system (Miltenyi) within its approved indication.
Evidence on the effectiveness of IA for ME/CFS including PCS exists only from clinical studies. This observational study aims to provide data to support a future randomized controlled trial (RCT).
- Being tested
- IA with TheraSorb ® column (Miltenyi)
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Post-COVID Syndrome (PCS), Immunoadsorption (IA), SF-36 Physical Function (PF)
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IA with TheraSorb ® column (Miltenyi)Device
Also called TheraSorb - Ig omni 1/5 adsorber, Immunoadsorption (IA)
IA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 is an established and widely used health-related quality of life measure. The 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 of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
Measured: 8 weeks after first IA
Secondary outcomes (8)
Improvement in ability to work in daily hours
Number of patients with an intra-patient change in his/her/their ability to work in daily hours from 6 months before first IA to 12 months after last IA.
Measured: before first IA; 3 and 6 months after last IA
Improvement in hand grip strength
Intra-patient change in hand grip strength from baseline to follow-up points assessed using the Handgrip-Muscle-Fatigue Test.
Measured: 8 weeks after first IA
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 follow-up points will be documented as indexed by the Chalder Fatigue Scale.
Measured: 8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score
The CCC Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). Intra-patient change in ME/CFS symptoms from baseline to follow-up points will be documented as indexed by the CCC Symptom Score.
Measured: 8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)
The 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: 8 weeks after first IA; 3 and 6 months after last IA
Decrease in ß2R autoantibodies and soluble biomarkers of disease
Intra-patient change in ß2R autoantibodies and soluble biomarkers of disease from baseline to follow-up points assessed.
Measured: 8 weeks after first IA
Correlation of treatment response with memory B-cells
Associations of intra-patient change in symptoms and profile or levels of memory B-cells from baseline to follow-up points.
Measured: 8 weeks after first IA
Verification of tolerability
Number of patients tolerating the IA treatment.
Measured: 8 weeks after last IA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start11 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Research, Technology, and Space (BMFTR), Weidenhammer-Zöbele Foundation
- Responsible party
- Principal investigator, Carmen Scheibenbogen, Charite University, Berlin, Germany
- Investigators
- Carmen Scheibenbogen, Prof. Dr., Principal investigator, Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529197
- Sponsor's protocol ID
- IMPACT
- Acronym
- IMPACT
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32751659Scheibenbogen 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 29543914Stein E, Heindrich C, Wittke K, Kedor C, Rust R, Freitag H, Sotzny F, Kruger A, Tolle M, Grabowski P, Scheibenbogen C, Kim L. Efficacy of repeated immunoadsorption in patients with post-COVID myalgic encephalomyelitis/chronic fatigue syndrome and elevated beta2-adrenergic receptor autoantibodies: a prospective cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101161. doi: 10.1016/j.lanepe.2024.101161. eCollection 2025 Feb.
PubMed 39759581Sotzny F, Filgueiras IS, Kedor C, Freitag H, Wittke K, Bauer S, Sepulveda N, Mathias da Fonseca DL, Baiocchi GC, Marques AHC, Kim M, Lange T, Placa DR, Luebber F, Paulus FM, De Vito R, Jurisica I, Schulze-Forster K, Paul F, Bellmann-Strobl J, Rust R, Hoppmann U, Shoenfeld Y, Riemekasten G, Heidecke H, Cabral-Marques O, Scheibenbogen C. Dysregulated autoantibodies targeting vaso- and immunoregulatory receptors in Post COVID Syndrome correlate with symptom severity. Front Immunol. 2022 Sep 27;13:981532. doi: 10.3389/fimmu.2022.981532. eCollection 2022.
PubMed 36238301Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
PubMed 36042189Scheibenbogen C, Kedor C, Behrends U. ME/CFS, Der niedergelassene Arzt, 12/2020
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT07529197
- Acronym / sponsor ID
- IMPACT / IMPACT
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Post-COVID Syndrome (PCS), Immunoadsorption (IA), SF-36 Physical Function (PF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Research, Technology, and Space (BMFTR), Weidenhammer-Zöbele Foundation
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (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.
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME/CFS criteria after six months. No causal treatment exists for ME/CFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies.
Immunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME/CFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME/CFS also showed symptomatic improvement in most patients.
Hypothesis:
Antibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME/CFS and is associated with altered memory B-cell profiles before treatment.
Objective:
To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.
The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.
Detailed description
Patients presenting to our outpatient clinic who meet the Canadian Consensus Criteria (CCC) for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC are also eligible for IA and study inclusion.
IA is performed independently of the study at the Diamedikum Potsdam. The standard clinical schedule includes five outpatient sessions on days 1, 2, 4, 6, and 8. This procedure follows routine clinical practice and is not influenced by study participation.
At study inclusion, all patients undergo baseline assessments including routine laboratory tests, immunoglobulins, autoantibodies, and biomarkers, with a total of 50 ml of blood collected. Additional diagnostic workup is performed as clinically indicated. The diagnosis of ME/CFS is confirmed using the CCC.
Health status and symptom severity are documented using validated questionnaires: SF-36 (Physical Function subscale), work ability (past 12 months), weighted CCC symptom score, Chalder Fatigue Questionnaire, and Bell Disability Scale. These are completed monthly for 12 months after treatment. To reduce participant burden, questionnaires are mailed to patients for home completion.
Further clinical and laboratory assessments are conducted before IA and at 2- and 6-months post-treatment: i) Handgrip strength, ii) NASA Lean Test, and iii) Blood sampling.
The total study duration per participant is 12 months after IA.
This is a non-interventional observational study following patients with ME/CFS or PCS undergoing IA using the TheraSorb® Immunoadsorption system (Miltenyi) within its approved indication.
Evidence on the effectiveness of IA for ME/CFS including PCS exists only from clinical studies. This observational study aims to provide data to support a future randomized controlled trial (RCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to our outpatient clinic who meet the CCC for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC criteria are also eligible for IA and study inclusion.
Key inclusion criteria (5 listed)
- Patients aged 18-65 years who are able to give informed consent and have: i) ME/CFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score < 60
- Presence of autoantibodies (adrenergic or antineuronal antibodies)
- Undergoing IA with the TheraSorb® column over 5 days
- Written informed consent provided by the patient
- Health insurance coverage
Key exclusion criteria (5 listed)
- Lack of willingness to store pseudonymized disease data as part of the study
- Pregnancy
- Presence of other conditions that prevent a definite ME/CFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)
- Acute infection (COVID, HIV, hepatitis)
- Severe fatigue disease with bedriddenness (Bell Disability Score < 30)
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 |
|---|---|---|
| IA with TheraSorb ® column (Miltenyi)Also: TheraSorb - Ig omni 1/5 adsorber, Immunoadsorption (IA)IA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice. | Device | – |
Primary outcome
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: 8 weeks after first IA
The SF-36 is an established and widely used health-related quality of life measure. The 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 of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
8 secondary outcomes
Improvement in ability to work in daily hours
Time frame: before first IA; 3 and 6 months after last IA
Improvement in hand grip strength
Time frame: 8 weeks after first IA
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
Time frame: 8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score
Time frame: 8 weeks after first IA; 3 and 6 months after last IA
Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)
Time frame: 8 weeks after first IA; 3 and 6 months after last IA
Decrease in ß2R autoantibodies and soluble biomarkers of disease
Time frame: 8 weeks after first IA
Correlation of treatment response with memory B-cells
Time frame: 8 weeks after first IA
Verification of tolerability
Time frame: 8 weeks after last IA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- 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.
- 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 39759581Stein E, Heindrich C, Wittke K, Kedor C, Rust R, Freitag H, Sotzny F, Kruger A, Tolle M, Grabowski P, Scheibenbogen C, Kim L. Efficacy of repeated immunoadsorption in patients with post-COVID myalgic encephalomyelitis/chronic fatigue syndrome and elevated beta2-adrenergic receptor autoantibodies: a prospective cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101161. doi: 10.1016/j.lanepe.2024.101161. eCollection 2025 Feb.
- Background: PubMed 36238301Sotzny F, Filgueiras IS, Kedor C, Freitag H, Wittke K, Bauer S, Sepulveda N, Mathias da Fonseca DL, Baiocchi GC, Marques AHC, Kim M, Lange T, Placa DR, Luebber F, Paulus FM, De Vito R, Jurisica I, Schulze-Forster K, Paul F, Bellmann-Strobl J, Rust R, Hoppmann U, Shoenfeld Y, Riemekasten G, Heidecke H, Cabral-Marques O, Scheibenbogen C. Dysregulated autoantibodies targeting vaso- and immunoregulatory receptors in Post COVID Syndrome correlate with symptom severity. Front Immunol. 2022 Sep 27;13:981532. doi: 10.3389/fimmu.2022.981532. eCollection 2022.
- Background: PubMed 36042189Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
- BackgroundScheibenbogen C, Kedor C, Behrends U. ME/CFS, Der niedergelassene Arzt, 12/2020
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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.
Carmen Scheibenbogen, Prof. Dr. principal investigator
Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and ME/CFS Following COVID-19, 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Apr 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa A Stein, Dr. (+49 450 624354, elisa.stein@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) (time frame: 8 weeks after first IA). 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 NCT07529197, which also lists 6 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 14 Apr 2026.