[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myalgic-encephalomyelitischronic-fatigue-syndrome-mecfs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myalgic-encephalomyelitischronic-fatigue-syndrome-mecfs":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":20,"type":21},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.",[25,26],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","ME\u002FCFS Following COVID-19",[25,28,29,30],"Post-COVID Syndrome (PCS)","Immunoadsorption (IA)","SF-36 Physical Function (PF)","RECRUITING","2026-04-13",{"date":34,"type":35},"2026-04-14","ACTUAL",{"date":37,"type":35},"2026-03-11",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"Charite University, Berlin, Germany","OTHER",""]