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LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions

NCT05293366 · Federico II University
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Official title
LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions
About this study
The aim of the study is to investigate whether in patients recovered from COVID-19 disease, SARS-CoV-2 infection has induced: 1) Endocrine-metabolic function damage, 2) Neuro-psychiatric damage, 3) Muscle damage, 4) Pulmonary damage, 5) Cardiological damage, 6) Post-thrombotic vascular damage, 7) Dermatological damage. The assessment of the potential endocrine-metabolic function damage will comprise the investigation of alterations in particular in: thyrotropic axis (prevalence of hypothyroidism and alterations of the thyroid gland); female gonadotropic axis (prevalence of hypogonadism) with assessment of potentially impaired reproductive and sexual function (prevalence of morpho-structural alterations of the ovary, sexual dysfunction); corticotropic axis (prevalence of hypoadrenalism and alterations of the adrenal gland); somatotropic axis (prevalence of growth hormone deficiency); lactotropic axis (prevalence of hyperprolactinaemia); metabolic profile (prevalence of metabolic syndrome, overweight, obesity, insulin resistance, type 2 diabetes mellitus, dyslipidemia, hypovitaminosis D). The assessment of the potential neuro-psychiatric damage will comprise the investigation of prevalence of depression, alteration in the quality of life, apathy, anxiety, deficit of attention and cognitive skills. The assessment of the potential muscle damage will comprise the investigation of prevalence of fatigue, reduced resistance and muscle strength, reduced muscle power, reduced exercise tolerance, myopathy. The assessment of the potential pulmonary damage will comprise the investigation of prevalence of parenchymal sequelae of interstitial/organized pneumonia, lung dysfunctions, dyspnoea. The assessment of the potential cardiological damage will comprise the investigation of prevalence of echocardiographic changes at rest and during echocardiogram stress tests, dysfunctions in cardiopulmonary performance. The assessment of the potential post-thrombotic vascular damage will comprise the investigation of prevalence of previously unknown deep venous thrombosis. The assessment of the potential dermatological damage will comprise the investigation of prevalence of cutaneous and mucosal lesions, defluvium with identification of specific trichoscopic patterns and onychopathies with identification of specific onychoscopic/capillaroscopic patterns. Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3-12 months.
Eligibility criteria
Inclusion Criteria: * Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG); * Aged over 18 years of age; * Ability to understand protocol procedures Exclusion Criteria: * Any psychological/psychiatric/other medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences * uncooperative attitude of the patient
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-01-27
Estimated completion: 2027-01-27
Last updated: 2025-08-08
Interventions
Diagnostic Test: Assessments of endocrinological phenotypes of LO-COCO patientsDiagnostic Test: Assessment of muscular phenotypes of LO-COCO patientsDiagnostic Test: Assessment of neuropsychiatric phenotypes of LO-COCO patientsProcedure: Muscle biopsyDiagnostic Test: Assessment of pulmonary phenotypes of LO-COCO patientsDiagnostic Test: Assessment of cardiological phenotypes of LO-COCO patientsDiagnostic Test: Assessment of vascular phenotypes of LO-COCO patientsDiagnostic Test: Assessment of dermatological phenotypes of LO-COCO patientsProcedure: Tissue biopsy
Primary outcomes
  • Identification of the most frequent phenotypes of Long-COVID syndrome among for COVID-19 patients recently hospitalized and dismissed (Change from baseline at 3-12 months)
Sponsor
Federico II University · other
With: Azienda Sanitaria Locale Napoli 2 Nord
Contacts & investigators
ContactAnnamaria Colao, Prof · contact · colao@unina.it · 3285390000
InvestigatorAnnamaria Colao, Prof · principal_investigator, Federico II University
All locations (1)
Federico II University of NaplesRecruiting
Naples, Italy
LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions · TrialPath