[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586138":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":31,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":42,"sex":43,"minAge":44,"maxAge":10,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":10,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Former PASC patients",null,"Former PASC patients or healthy controls. Fatigue Severity Scale ≥ 4 at time of inclusion",{"label":13,"type":10,"description":14,"interventionNames":10},"PASC patients","PASC patients with persistent dyspnea and fatigue. Fatigue Severity Scale ≤ 4 at time of \\[68Ga\\]FAPI PET\u002FCT after having previously recorded score of ≥ 4 or equivalent.",{"label":16,"type":10,"description":17,"interventionNames":10},"Back-up cohort - 'healthy' controls","Patients without self-reported complaints and past SARS-CoV-2 infection (which would have resulted in a Fatigue Severity Scale ≤ 4) or without experienced confirmed SARS-CoV-2 infection.",[19],{"name":20,"affiliation":21,"role":22},"J Pillay, MD PhD","Department of Intensive Care, University Medical Center Groningen","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Research Desk UMCG - LIBERATE","CONTACT","+31652724087","LIBERATE@umcg.nl",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[32],{"name":33,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","100586138","from-inflammation-to-remodelling-towards-personalized-diagnosis-in-post-acute-sequelae-of-covid-19-100586138",false,"NCT06911476","From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19","From Inflammation Biomarkers to Remoddeling (FAPI PET\u002FCT) Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19","LIBERATE","Inclusion Criteria:\n\n\\- Self-reported complaints of dyspnea or fatigue \\> 3 months after SARS-CoV-2 infection confirmed with PCR, serology test or COVID-19 Reporting and Data System (CO-RADS) score 4\u002F5.\n\nExclusion Criteria:\n\n* Inability or unwilling to give informed consent.\n* History of claustrophobia or feeling of inability to tolerate supine position for the PET\u002FCT scans.\n* Individuals who are pregnant or currently breastfeeding are not eligible to participate",true,"ALL","20 Years",{"count":46,"type":47},60,"ESTIMATED","OBSERVATIONAL","Rationale: The diagnosis and pathogenesis of long COVID remains unknown. We have previously shown that \\[68Ga\\]FAPI Positron Emission Tomography-Computed Tomography (PET\u002FCT) imaging shows potential for diagnosis and molecular understanding of this syndrome. We have previously shown that fibroblast activation protein (FAP) can be imaged in the lung, muscle and nasopharynx of long COVID patients (with dyspnea and fatigue). However, these preliminary data are derived from a selective group of patients with long COVID after critical COVID-19. We aim to explore the generalizability of these findings in patients with long COVID with dyspnea and fatigue, irrespective of the severity of their acute SARS-CoV-2 infection.\n\nPrimary objective: To assess if pulmonary fibroblast activity, measured by \\[68Ga\\]FAPI-46 PET\u002FCT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.\n\nStudy design: This is a ZonMw funded single centre prospective observational cohort study of long COVID-19 patients with dyspnea and fatigue.\n\nStudy population: We will recruit 60 adult long COVID patients (aged \\>20 years) of which 30 have complaints of dyspnea and fatigue and compare them to 30 patients with resolved complaints and healthy controls.\n\nMain study parameters\u002Fendpoints: The primary endpoint is FAP expression in the lung measured by \\[68Ga\\]FAPI-46 PET\u002FCT. Secondary endpoints are the expression of FAP in other tissues (muscle) and the relation between FAP and inflammation and remodelling biomarkers in various biological samples (e.g. serum\u002Fnasal epithelium).\n\nStudy procedures: In a single visit day the following data and samples will be collected: questionnaires, a lung function test, 6-minute walking test, blood samples, nose swabs, \\[68Ga\\]FAPI PET\u002FCT scan and HRCT scan. When increased \\[68Ga\\]FAPI uptake is measured in the muscles a muscle biopsy will be performed as well.",[51,52,53,54,55,56,57,58,59],"PASC Post Acute Sequelae of COVID 19","Long COVID","Long Covid-19","PASC","FAPI","FAP","Fibroblast Activation Protein Inhibitor","Fibroblast","Restrictive Lung Disease","NOT_YET_RECRUITING","2025-04-03",{"date":63,"type":64},"2025-04-04","ACTUAL",{"date":66,"type":47},"2025-05",{"date":68,"type":47},"2025-12",{"name":5,"class":6}]