protocolSection identificationModule nctId: NCT06279936, orgStudyIdInfo id: B3002021000171, briefTitle: Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID, acronym: Cov-N-Psy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: UZA Foundation, descriptionModule briefSummary: Objectives:To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.Study design:Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients., conditionsModule conditions: Long COVID, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Neuropsychological battery, interventions name: Surveys and symptom severity questionnaires, interventions name: Blood withdrawal, interventions name: Saliva swabs, outcomesModule primaryOutcomes measure: Concentration of immunological and HPA-axis markers, secondaryOutcomes measure: Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints, secondaryOutcomes measure: Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SINAPS, city: Duffel, state: Antwerp, zip: 2570, country: Belgium, geoPoint lat: 51.09554, lon: 4.50903, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-10-01, uploadDate: 2024-02-08T04:56, filename: Prot_SAP_000.pdf, size: 1140716, hasResults: False