Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-05 @ 11:37 AM
Study NCT ID:
NCT05293366
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2022-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-19', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of the most frequent phenotypes of Long-COVID syndrome among for COVID-19 patients recently hospitalized and dismissed', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'This pilot study will allow identifying the frequency and type of endocrinologic, muscular, cardiovascular, pulmonary, dermatological, metabolic and neuropsychiatric disorders that contribute to the long covid syndrome .'}], 'secondaryOutcomes': [{'measure': 'Thyroid dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of thyroid dysfunctions (hypo, hyper functions; thyroiditis)'}, {'measure': 'Female gonadal dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of female gonadal dysfunctions (hypogonadism and female sexual dysfunctions)'}, {'measure': 'Adrenal dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of adrenal dysfunctions (hypocortisolism)'}, {'measure': 'Pituitary dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of pituitary dysfunctions (hyperprolactinemia, GH deficiency)'}, {'measure': 'Metabolic dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of metabolic dysfunctions (metabolic syndrome, type 2 diabetes, overweight, obesity, insulin-resistance, dyslipidemia, hypovitaminosis D)'}, {'measure': 'Neuro-psychiatric dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of depression, alteration of the quality of life, apathy, anxiety, deficit of attentional and cognitive skills'}, {'measure': 'Muscle dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of fatigue, reduced resistance and muscle strength, reduced muscle power, reduced exercise tolerance, myopathy.'}, {'measure': 'Pulmonary dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of persisting respiratory discomfort in relation to lung function and radiological outcomes (interstitial/organized pneumonia, pulmonary fibrosis)'}, {'measure': 'Cardiological dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of echocardiographic changes at rest and during echocardiogram stress tests, dysfunctions in cardiopulmonary performance'}, {'measure': 'Post-thrombotic vascular dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of previously unknown deep venous thrombosis'}, {'measure': 'Dermatological dysfunctions', 'timeFrame': 'Change from baseline at 3-12 months', 'description': 'Prevalence of cutaneous and mucosal lesions, defluvium with identification of specific trichoscopic patterns and onychopathies with identification of specific onychoscopic/capillaroscopic patterns.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long Covid-19', 'Endocrine Complications', 'Metabolic Complications', 'Neuropsychiatric Complications', 'Muscular Complications', 'Cardiovascular Complications', 'Pulmonary Complications', 'Dermatologic Complications'], 'conditions': ['Long Covid-19']}, 'referencesModule': {'references': [{'pmid': '34037973', 'type': 'BACKGROUND', 'citation': 'Auriemma RS, Pirchio R, Liccardi A, Scairati R, Del Vecchio G, Pivonello R, Colao A. Metabolic syndrome in the era of COVID-19 outbreak: impact of lockdown on cardiometabolic health. J Endocrinol Invest. 2021 Dec;44(12):2845-2847. doi: 10.1007/s40618-021-01563-y. Epub 2021 May 26.'}, {'pmid': '33020736', 'type': 'BACKGROUND', 'citation': 'Fabbrocini G, Vastarella M, Nappa P, Annunziata MC, Camela E, Greco V, Gaudiello F, Alessio M, Pierri L, Catzola A, Guarino A. A new dermoscopic pattern for chilblain-COVID-19-like skin lesions in adolescents. JAAD Case Rep. 2020 Dec;6(12):1271-1274. doi: 10.1016/j.jdcr.2020.09.024. Epub 2020 Oct 1. No abstract available.'}, {'pmid': '33359928', 'type': 'BACKGROUND', 'citation': 'Ortelli P, Ferrazzoli D, Sebastianelli L, Engl M, Romanello R, Nardone R, Bonini I, Koch G, Saltuari L, Quartarone A, Oliviero A, Kofler M, Versace V. Neuropsychological and neurophysiological correlates of fatigue in post-acute patients with neurological manifestations of COVID-19: Insights into a challenging symptom. J Neurol Sci. 2021 Jan 15;420:117271. doi: 10.1016/j.jns.2020.117271. Epub 2020 Dec 14.'}, {'pmid': '33660272', 'type': 'BACKGROUND', 'citation': 'Ocampo-Garza SS, Vastarella M, Nappa P, Cantelli M, Fabbrocini G. Telogen effluvium in the new SARS-CoV-2 era. Int J Dermatol. 2021 Jul;60(7):e265-e266. doi: 10.1111/ijd.15482. Epub 2021 Mar 4. No abstract available.'}, {'pmid': '33242856', 'type': 'BACKGROUND', 'citation': 'Pivonello R, Auriemma RS, Pivonello C, Isidori AM, Corona G, Colao A, Millar RP. Sex Disparities in COVID-19 Severity and Outcome: Are Men Weaker or Women Stronger? Neuroendocrinology. 2021;111(11):1066-1085. doi: 10.1159/000513346. Epub 2020 Nov 26.'}, {'pmid': '32286533', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Barrea L, Savastano S, Colao A. Nutritional recommendations for CoVID-19 quarantine. Eur J Clin Nutr. 2020 Jun;74(6):850-851. doi: 10.1038/s41430-020-0635-2. Epub 2020 Apr 14. No abstract available.'}, {'pmid': '32353356', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Pugliese G, Barrea L, Savastano S, Colao A. Commentary: Obesity: The "Achilles heel" for COVID-19? Metabolism. 2020 Jul;108:154251. doi: 10.1016/j.metabol.2020.154251. Epub 2020 Apr 27. No abstract available.'}, {'pmid': '32335855', 'type': 'BACKGROUND', 'citation': 'Isidori AM, Arnaldi G, Boscaro M, Falorni A, Giordano C, Giordano R, Pivonello R, Pofi R, Hasenmajer V, Venneri MA, Sbardella E, Simeoli C, Scaroni C, Lenzi A. COVID-19 infection and glucocorticoids: update from the Italian Society of Endocrinology Expert Opinion on steroid replacement in adrenal insufficiency. J Endocrinol Invest. 2020 Aug;43(8):1141-1147. doi: 10.1007/s40618-020-01266-w. Epub 2020 Apr 25. No abstract available.'}, {'pmid': '32488724', 'type': 'BACKGROUND', 'citation': 'Bellastella G, Maiorino MI, Esposito K. Endocrine complications of COVID-19: what happens to the thyroid and adrenal glands? J Endocrinol Invest. 2020 Aug;43(8):1169-1170. doi: 10.1007/s40618-020-01311-8. Epub 2020 Jun 1. No abstract available.'}, {'pmid': '32527756', 'type': 'BACKGROUND', 'citation': 'Agarwal S, Agarwal SK. Endocrine changes in SARS-CoV-2 patients and lessons from SARS-CoV. Postgrad Med J. 2020 Jul;96(1137):412-416. doi: 10.1136/postgradmedj-2020-137934. Epub 2020 Jun 11.'}, {'pmid': '32644129', 'type': 'BACKGROUND', 'citation': 'Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.'}, {'pmid': '33256813', 'type': 'BACKGROUND', 'citation': "D'Alto M, Marra AM, Severino S, Salzano A, Romeo E, De Rosa R, Stagnaro FM, Pagnano G, Verde R, Murino P, Farro A, Ciccarelli G, Vargas M, Fiorentino G, Servillo G, Gentile I, Corcione A, Cittadini A, Naeije R, Golino P. Right ventricular-arterial uncoupling independently predicts survival in COVID-19 ARDS. Crit Care. 2020 Nov 30;24(1):670. doi: 10.1186/s13054-020-03385-5."}, {'pmid': '32750108', 'type': 'BACKGROUND', 'citation': 'Evans PC, Rainger GE, Mason JC, Guzik TJ, Osto E, Stamataki Z, Neil D, Hoefer IE, Fragiadaki M, Waltenberger J, Weber C, Bochaton-Piallat ML, Back M. Endothelial dysfunction in COVID-19: a position paper of the ESC Working Group for Atherosclerosis and Vascular Biology, and the ESC Council of Basic Cardiovascular Science. Cardiovasc Res. 2020 Dec 1;116(14):2177-2184. doi: 10.1093/cvr/cvaa230.'}]}, 'descriptionModule': {'briefSummary': 'Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of SARS-CoV-2 infection, the purpose 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) venous vascular damage; 7) dermatological damage. Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.', 'detailedDescription': '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.\n\nThe 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).\n\nThe 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.\n\nThe 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.\n\nThe assessment of the potential pulmonary damage will comprise the investigation of prevalence of parenchymal sequelae of interstitial/organized pneumonia, lung dysfunctions, dyspnoea.\n\nThe 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.\n\nThe assessment of the potential post-thrombotic vascular damage will comprise the investigation of prevalence of previously unknown deep venous thrombosis.\n\nThe 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.\n\nPatients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients of both sexes recovered from SARS-CoV-2 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG);\n* Aged over 18 years of age;\n* Ability to understand protocol procedures\n\nExclusion Criteria:\n\n* Any psychological/psychiatric/other medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences\n* uncooperative attitude of the patient'}, 'identificationModule': {'nctId': 'NCT05293366', 'acronym': 'LO-COCO', 'briefTitle': 'LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions', 'orgStudyIdInfo': {'id': 'LO-COCO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessments of endocrinological phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Evaluation of hormonal and metabolic health'], 'description': 'Assessment of:thyroid-stimulating hormone(TSH),free triiodothyronine (FT3), free thyroxine (FT4),calcitonin,antibodies against thyroglobulin (AbTG) and against thyroperoxidase (AbTPO),adrenocorticotropic hormone (ACTH),cortisol, luteinizing hormone (LH),follicle-stimulating hormone(FSH),Testosterone,17-beta estradiol,sex hormone binding globulin (SHBG),progesterone, prolactin (PRL), growth hormone (GH), insulin growth factor-1 (IGF-1), dehydroepiandrosterone sulphate (DHEAS),delta 4-androstenedione,aldosterone,renin,glycemia, insulinemia, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, HbA1c, vitamin D, adiponectin, irisin, IL-6.Thyroid and ovarian ultrasounds, pituitary and adrenal MRI will be performed as well. Body composition will be assessed with bioimpedance analysis and DXA scans.Female sexual dysfunctions will be evaluated with Female Sexual Function Index (FSFI), Sexual Inhibition and Sexual Excitation Scale (SIS/SES),Body Uneasiness Test (BUT).'}, {'name': 'Assessment of muscular phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questions will be collected regarding the tolerance to physical activity and modifications after diagnosis of Covid. Muscular strength will be assessed by means of tests (Medical Research Council Scale) and dynamometers. Balance will be assessed with a Romberg test, tolerance to stress will be assessed by means of cyclometer.'}, {'name': 'Assessment of neuropsychiatric phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'Validated questionnaires will be collected to investigate depression (Beck Depression Inventory-II, BDI-II), apathy (Apathy Evaluation Scale, AES), anxiety (Test Anxiety Inventory, TAI), attention and cognitive functions (Montreal Cognitive Assessment and Quick Mild Cognitive Impairment). Fatigue will be assessed by Fatigue Rating Scale (FRS) and Fatigue Severity Scale (FSS). Muscle power will be assessed by six-minute walking test and sit and stand up test. The presence of myopathy will be evaluated by mean electrophysiological study.'}, {'name': 'Muscle biopsy', 'type': 'PROCEDURE', 'description': 'Muscle biopsy will be performed upon need.'}, {'name': 'Assessment of pulmonary phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'Modified Medical Research council questionnaire will be administered for evaluating of the dyspnoea level. Complete respiratory status assessment, including global spirometry, CO lung diffusion capacity and arterial gases analysis will be run. HRCT - high resolution CT scan of the chest - will be performed in selected cases to rule out the eventual sequelae of SARS-Cov2 related pneumonia.'}, {'name': 'Assessment of cardiological phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiological assessment will be run upon data collected from: Short Form-36 Health Survey (SF36), echocardiogram at rest and during stress tests, six-minute walking test, N-terminal fragment brain natriuretic peptides (NT-proBNP)'}, {'name': 'Assessment of vascular phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'The assessment of the potential post-thrombotic vascular damage will comprise the investigation of prevalence of previously unknown deep venous thrombosis by ultrasonography.'}, {'name': 'Assessment of dermatological phenotypes of LO-COCO patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dermatology evaluation will account on: thrichoscopy, dermoscopy, onychoscopy and capillaroscopy, confocal microscopy, skin ultrasonography'}, {'name': 'Tissue biopsy', 'type': 'PROCEDURE', 'description': 'Tissue biopsy will be performed upon need.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annamaria Colao, Prof', 'role': 'CONTACT', 'email': 'colao@unina.it', 'phone': '3285390000'}], 'facility': 'Federico II University of Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Annamaria Colao, Prof', 'role': 'CONTACT', 'email': 'colao@unina.it', 'phone': '3285390000'}], 'overallOfficials': [{'name': 'Annamaria Colao, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Sanitaria Locale Napoli 2 Nord', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Annamaria Colao', 'investigatorAffiliation': 'Federico II University'}}}}