[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633631":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":48,"id":54,"slug":7,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":7,"studyType":67,"phases":7,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany",{"type":36,"coordinates":37},"Point",[38,39],13.41053,52.52437,{"lat":39,"lon":38},[42],{"name":18,"role":24,"phone":43,"phoneExt":7,"email":44},"+49 30 450 524103","carmen.scheibenbogen@charite.de",{"type":20,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Carmen Scheibenbogen","Director of the Institute for Medical Immunology (Prof. Dr. med.)",[49,52],{"name":50,"class":51},"German Federal Ministry of Research, Technology, and Space (BMFTR)","UNKNOWN",{"name":53,"class":51},"Weidenhammer-Zöbele Foundation","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":65,"type":66},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.",[70,71],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","ME\u002FCFS Following COVID-19",[70,73,15,74],"Post-COVID Syndrome (PCS)","SF-36 Physical Function (PF)","2026-04-13",{"date":77,"type":78},"2026-04-14","ACTUAL",{"date":80,"type":78},"2026-03-11",{"date":82,"type":66},"2027-12-31",{"name":5,"class":6},1]