[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633631":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":49,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":7,"studyType":69,"phases":7,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","IA with TheraSorb ® column (Miltenyi)","IA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice.",[14,15],"TheraSorb - Ig omni 1\u002F5 adsorber","Immunoadsorption (IA)",[17],{"name":18,"affiliation":19,"role":20},"Carmen Scheibenbogen, Prof. Dr.","Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,","PRINCIPAL_INVESTIGATOR",[22],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Elisa A Stein, Dr.","CONTACT","+49 450 624354","elisa.stein@charite.de",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],13.41053,52.52437,{"lat":40,"lon":39},[43],{"name":18,"role":24,"phone":44,"phoneExt":7,"email":45},"+49 30 450 524103","carmen.scheibenbogen@charite.de",{"type":20,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Carmen Scheibenbogen","Director of the Institute for Medical Immunology (Prof. Dr. med.)",[50,53],{"name":51,"class":52},"German Federal Ministry of Research, Technology, and Space (BMFTR)","UNKNOWN",{"name":54,"class":52},"Weidenhammer-Zöbele Foundation","100633631","observational-study-on-immunoadsorption-ia-in-patients-with-autoantibody-positive-post-infectious-mecfs-100633631",false,"NCT07529197","Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME\u002FCFS","Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","IMPACT","Inclusion Criteria:\n\n* Patients aged 18-65 years who are able to give informed consent and have: i) ME\u002FCFS 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 \\\u003C 60\n* Presence of autoantibodies (adrenergic or antineuronal antibodies)\n* Undergoing IA with the TheraSorb® column over 5 days\n* Written informed consent provided by the patient\n* Health insurance coverage\n\nExclusion Criteria:\n\n* Lack of willingness to store pseudonymized disease data as part of the study\n* Pregnancy\n* Presence of other conditions that prevent a definite ME\u002FCFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)\n* Acute infection (COVID, HIV, hepatitis)\n* Severe fatigue disease with bedriddenness (Bell Disability Score \\\u003C 30)","ALL","18 Years","65 Years",{"count":67,"type":68},50,"ESTIMATED","OBSERVATIONAL","Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) 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\u002FCFS criteria after six months. No causal treatment exists for ME\u002FCFS 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.\n\nImmunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME\u002FCFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME\u002FCFS also showed symptomatic improvement in most patients.\n\nHypothesis:\n\nAntibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME\u002FCFS and is associated with altered memory B-cell profiles before treatment.\n\nObjective:\n\nTo observe and document symptom progression in 50 ME\u002FCFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.\n\nThe study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.",[72,73],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","ME\u002FCFS Following COVID-19",[72,75,15,76],"Post-COVID Syndrome (PCS)","SF-36 Physical Function (PF)","2026-04-13",{"date":79,"type":80},"2026-04-14","ACTUAL",{"date":82,"type":80},"2026-03-11",{"date":84,"type":68},"2027-12-31",{"name":5,"class":6},1]