Repeat Immunoadsorption Post Covid ME/CFS

NCT05629988 | Completed

• 2 other identifiers: IAINPCS01EP2201
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-COVID ME/CFS

Keywords

Post-COVID Syndrome; Long COVID; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.

  4 weeks after first IA

Secondary Outcomes (12)

• Efficacy of repeat immunoadsorptions (IA) on Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)

  3 - 6 months after first IA

• Response duration of repeat immunoadsorptions (IA) on Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)

  3 - 6 months after first IA

• Improvement in ability to work in daily hours

  12 months after last IA

• Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale

  4 weeks after first IA; 6 and 12 months after last IA

• Improvement in fatigue as measured by the Fatigue Severity Score (FSS)

  4 weeks after first IA; 6 and 12 months after last IA

Interventions

IA with TheraSorb ® column DEVICE

IA cycle is 5 days, repeat cycles will be given to responders at months 3 and 6

Eligibility Criteria

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

Study Population

Patients presenting at the investigators' outpatient clinic who meet the CCC for ME/CFS (PEM for at least 14h or longer) and who are found to have elevated ß2R autoantibodies will be offered an IA and participation in this observational study. Also, PCS patients who do not meet CCC criteria due to shorter PEM (\< 14h) but meet Systemic Exertion Intolerance Disease criteria may receive IA and be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• Lack of willingness to store pseudonymized disease data as part of the study
• Pregnancy
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (6)

• Kedor 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.

  PMID: 36042189 BACKGROUND

• Sotzny F, Blanco J, Capelli E, Castro-Marrero J, Steiner S, Murovska M, Scheibenbogen C; European Network on ME/CFS (EUROMENE). Myalgic Encephalomyelitis/Chronic Fatigue Syndrome - Evidence for an autoimmune disease. Autoimmun Rev. 2018 Jun;17(6):601-609. doi: 10.1016/j.autrev.2018.01.009. Epub 2018 Apr 7.

  PMID: 29635081 BACKGROUND

• Freitag H, Szklarski M, Lorenz S, Sotzny F, Bauer S, Philippe A, Kedor C, Grabowski P, Lange T, Riemekasten G, Heidecke H, Scheibenbogen C. Autoantibodies to Vasoregulative G-Protein-Coupled Receptors Correlate with Symptom Severity, Autonomic Dysfunction and Disability in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. J Clin Med. 2021 Aug 19;10(16):3675. doi: 10.3390/jcm10163675.

  PMID: 34441971 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

• Stein E, Heindrich C, Wittke K, Kedor C, Kim L, Freitag H, Kruger A, Tolle M, Scheibenbogen C. Observational Study of Repeat Immunoadsorption (RIA) in Post-COVID ME/CFS Patients with Elevated ss2-Adrenergic Receptor Autoantibodies-An Interim Report. J Clin Med. 2023 Oct 9;12(19):6428. doi: 10.3390/jcm12196428.

  PMID: 37835071 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Institute for Medical Immunology

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 29, 2022
• Study Start: August 28, 2022
• Primary Completion: February 11, 2025
• Study Completion: March 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)