[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-acute-covid-19-vaccination-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-acute-covid-19-vaccination-syndrome":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100623762","clinical-laboratory-evaluation-assessment-of-symptoms-and-recovery-in-patients-with-post-covid-19-vaccination-syndrome-100623762",false,"NCT07400848","Clinical Laboratory Evaluation, Assessment of Symptoms and Recovery in Patients With Post-COVID-19-Vaccination Syndrome","CLEAR","General Criteria (apply to all study parts: PROGRESS, ENDOCLOT, REAL, patients and matched healthy controls)\n\nInclusion Criteria\n\n1. Age ≥ 18 years\n2. Sufficient knowledge of German to complete study-related questionnaires and procedures\n\nExclusion Criteria\n\n1. Severe cognitive, physical impairment or psychiatric conditions impeding participation\n2. Active oncological disease or immunosuppressive\n3. Known pregnancy at the time of enrolment\n\nPROGRESS (patients only)\n\nInclusion Criteria\n\n1. Coded participation with online consent confirmation\n2. Self-reported onset of persistent symptoms temporally associated with a COVID-19 vaccination\n3. Willingness and ability to participate in the 8-month follow-up period\n\nExclusion Criteria\n\n1\\. No specific exclusion criteria for this part\n\nENDOCLOT and REAL (patients and matched healthy controls)\n\nInclusion Criteria\n\n1. Signed informed consent form\n2. For patients:\n\n   1. Receipt of at least one COVID-19 vaccination\n   2. Onset of new, otherwise unexplained symptoms within 0-14 days after vaccination\n   3. Persistence of symptoms for at least 6 months following vaccination\n   4. Selection is based on a diagnosis of ME\u002FCFS according to the Canadian Consensus Criteria (CCC) and PEM.\n\n2\\. For controls: History of COVID-19 vaccination without persistent adverse effects; age (+\u002F- 10 years), and sex match to a corresponding case\n\nExclusion Criteria (patients and matched healthy controls)\n\n1. Clinically suspected or laboratory confirmed SARS-CoV-2 infection after vaccination or temporally related to symptom onset.\n2. Concurrent pre-existing Long COVID symptoms, obtained from the patient´s history\n3. Any self-reported or uncertain history of an acute infectious event (including mild or subclinical infections) in temporal proximity to COVID-19 vaccination\n4. Known pre-existing medical conditions or ongoing medications that could plausibly explain the reported symptoms (e.g., preexisting ME\u002FCFS, POTS, fibromyalgia, small-fiberneuropathy, autoimmune disease with systemic involvement or other chronic multisystemic dysautonomia syndromes)\n5. Use of long-term, high-dose anti-inflammatory",true,"ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Some people report persistent health problems after receiving the COVID-19 vaccine. These symptoms persist well beyond typical short-term vaccine side effects and are not attributable to any other known medical conditions. This condition is known as Post-Acute COVID-19 Vaccination Syndrome (PACVS). Symptoms can persist for months and affect several organ systems, causing issues such as fatigue, heart-related problems, neurological difficulties, and decreases in both physical ability and mental performance. PACVS shows similarities to Post-Acute COVID-19 syndrome (PACS) and myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS).\n\nThe biological processes that cause PACVS are still not fully understood. Recent research indicates that endothelial dysfunction, abnormalities in blood coagulation, and persistent inflammatory responses may contribute significantly to this process. However, it remains unclear how symptoms develop over time, which biological markers are associated with disease severity, and how these findings could support diagnosis and future treatment strategies.\n\nThe CLEAR study is an observational research project designed to address these knowledge gaps by systematically documenting symptoms over time and investigating potential biological correlates in individuals affected by PACVS. The study consists of three complementary subprojects.\n\nThe PROGRESS subproject aims to assess symptom burden, disease course, and patient-reported treatment experiences over an eight-month period using standardized questionnaires completed by participants.\n\nThe ENDOCLOT subproject investigates whether individuals with PACVS show objective signs of endothelial dysfunction, abnormalities in blood clotting, and markers of systemic inflammation. Endothelial function will be evaluated through non-invasive vascular reactivity tests (EndoPAT), microscopic examination of blood cells, standardized platelet function assessments, and standard laboratory diagnostics. It further explores the correlation between these biological parameters and clinical symptom trajectories identified in PROGRESS.\n\nThe REAL subproject examines the role of endothelial activation and the release of inflammatory signaling molecules (cytokines) in the development and persistence of PACVS.\n\nThe main hypothesis of the CLEAR study is that PACVS is associated with measurable endothelial dysfunction, inflammatory activation, and coagulation abnormalities, and that these biological changes are related to symptom severity and persistence over time. By combining longitudinal symptom assessment with biological measurements, this study aims to improve understanding of PACVS and support the development of better diagnostic and therapeutic approaches in the future.",[25,26],"Post-Acute COVID-19 Vaccination Syndrome","Postviral Fatigue",[28,29,30,31,32,33,34,35,36],"Vaccine-Related Adverse Event","Endothelial Dysfunction","Coagulation Abnormalities","Inflammation","Cytokines","Patient-Reported Outcomes","Symptom Burden","Disease Trajectory","Reactive Hyperemia Index","RECRUITING","2026-05-04",{"date":40,"type":41},"2026-05-05","ACTUAL",{"date":43,"type":41},"2026-03-22",{"date":45,"type":21},"2026-11-15",{"name":47,"class":48},"University of Bern","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100590439","phase-2-effect-of-metabolic-modulation-on-a-post-acute-covid-19-vaccination-syndrome-pacvs-cohort-100590439","NCT06967428","Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort","Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study","ViTAL-SCAN19","Inclusion Criteria:\n\n* Persistent fatigue lasting more than 6 months\n* Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)\n* Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.\n\nExclusion Criteria:\n\n* Pregnant\n* History of Schizophrenia\n* Currently using antidepressant medication","16 Years",{"count":60,"type":21},100,"INTERVENTIONAL",[63],"PHASE2","The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.\n\nThe main questions it aims to answer are:\n\nDoes the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?\n\nDoes the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?\n\nResearchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.\n\nParticipants will:\n\nTake the assigned supplement daily for 3 months (ViTAL SCAN or placebo)\n\nAttend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring\n\nComplete quality of life and health behavior questionnaires\n\nUndergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)\n\nRecord supplement intake\n\nThis study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.",[66,67],"Vaccine Adverse Reaction","Post Acute Covid-19 Vaccination Syndrome",[67,69,70],"Metabolic Modulation","Amino Acids","NOT_YET_RECRUITING","2025-05-05",{"date":74,"type":41},"2025-05-13",{"date":76,"type":21},"2025-09-01",{"date":78,"type":21},"2026-01",{"name":80,"class":48},"Independent Medical Alliance"]