NCT05629988Completed
Repeat Immunoadsorption Post Covid ME/CFS
Observational Study of Repeat Immunoadsorption (RIA) in Post Covid ME/CFS Patients With Elevated ß2 Adrenergic Receptor Autoantibodies
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
The evidence for an autoimmune etiology in postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is growing. The investigators observed in a not yet published study that in ME/CFS triggered by COVID, similar to ME/CFS after other infections, there is a close correlation of ß2 adrenergic receptor (ß2R) autoantibodies with symptom severity. Immunoadsorption (IA) to remove autoantibodies has been used successfully in many autoantibody-mediated diseases. The investigators have already performed two proof of concept studies of IA in postinfectious ME/CFS with elevated ß2R antibodies, which resulted in improvement in most patients. This observational study aims to assess symptom outcome and functional ability in 20 patients with Post-COVID Syndrome (PCS) meeting ME/CFS diagnostic criteria with elevated ß2R antibodies undergoing antibody depletion by IA. The study will be conducted as a non-interventional observational study. IA with Miltenyi's TheraSorb® column in PCS will be performed in the approved use. Patients who have symptom improvement after the 1st IA will receive two additional IAs at 3 and 6 months, which will also be documented. The results of this observational study will provide the basis for a randomized controlled clinical trial (RCT) combining IA with B-cell depletion therapy preferentially with Obinutuzumab.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 14 Nov 2022
- Start date
- 28 Aug 2022
- Primary completion date
- 11 Feb 2025
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05629988
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 28 Aug 2022 to the primary completion date, 11 Feb 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.
Other illness
- Lack of willingness to store pseudonymized disease data as part of the study
- Other illnesses that do not allow the diagnosis of PCS to be made with certainty (e.g., heart failure, lung disease, severe depression, cancer)
- Acute infection (COVID, HIV, hepatitis)
- Severe fatigue disease with bedriddenness
Other
- Pregnancy
Who the study is looking for
- Consenting patients aged 18-65 years with a diagnosis of Post-COVID ME/CFS according to the Canadian Consensus Criteria (CCC) or fulfilling CCC with exertion intolerance with symptom worsening (post exertional malaise = PEM) duration of less than 14 hours (thus fulfilling Institute of Medicine criteria)
- Evidence of COVID infection at disease onset (PCR) or N-IgG
- Detection of autoantibodies (elevated ß2 receptor adrenergic autoantibodies)
- Immunoadsorption with the TheraSorb® column for 5 days
- Health insurance
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.