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

NCT05293366 | Recruiting DMC

• 1 other identifier: LO-COCO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long Covid-19

Keywords

Long Covid-19; Endocrine Complications; Metabolic Complications; Neuropsychiatric Complications; Muscular Complications; Cardiovascular Complications; Pulmonary Complications; Dermatologic Complications

Outcome Measures

Primary Outcomes (1)

• Identification of the most frequent phenotypes of Long-COVID syndrome among for COVID-19 patients recently hospitalized and dismissed

  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 .

  Change from baseline at 3-12 months

Secondary Outcomes (11)

• Thyroid dysfunctions

  Change from baseline at 3-12 months

• Female gonadal dysfunctions

  Change from baseline at 3-12 months

• Adrenal dysfunctions

  Change from baseline at 3-12 months

• Pituitary dysfunctions

  Change from baseline at 3-12 months

• Metabolic dysfunctions

  Change from baseline at 3-12 months

Interventions

Assessments of endocrinological phenotypes of LO-COCO patients DIAGNOSTIC_TEST

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).

Also known as: Evaluation of hormonal and metabolic health

Assessment of muscular phenotypes of LO-COCO patients DIAGNOSTIC_TEST

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.

Assessment of neuropsychiatric phenotypes of LO-COCO patients DIAGNOSTIC_TEST

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.

Muscle biopsy PROCEDURE

Muscle biopsy will be performed upon need.

Assessment of pulmonary phenotypes of LO-COCO patients DIAGNOSTIC_TEST

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.

Assessment of cardiological phenotypes of LO-COCO patients DIAGNOSTIC_TEST

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)

Assessment of vascular phenotypes of LO-COCO patients DIAGNOSTIC_TEST

The assessment of the potential post-thrombotic vascular damage will comprise the investigation of prevalence of previously unknown deep venous thrombosis by ultrasonography.

Assessment of dermatological phenotypes of LO-COCO patients DIAGNOSTIC_TEST

Dermatology evaluation will account on: thrichoscopy, dermoscopy, onychoscopy and capillaroscopy, confocal microscopy, skin ultrasonography

Tissue biopsy PROCEDURE

Tissue biopsy will be performed upon need.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients of both sexes recovered from SARS-CoV-2 infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead
• Azienda Sanitaria Locale Napoli 2 Nord: collaborator

Study Sites (1)

Federico II University of Naples

Naples, 80131, Italy

RECRUITING

Related Publications (13)

• 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: 34037973 BACKGROUND

• 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: 33020736 BACKGROUND

• 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: 33359928 BACKGROUND

• 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: 33660272 BACKGROUND

• 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: 33242856 BACKGROUND

• 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: 32286533 BACKGROUND

• 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: 32353356 BACKGROUND

• 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: 32335855 BACKGROUND

• 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: 32488724 BACKGROUND

• 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: 32527756 BACKGROUND

• 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: 32644129 BACKGROUND

• 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: 33256813 BACKGROUND

• 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.

  PMID: 32750108 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annamaria Colao, Prof

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Colao, Prof

CONTACT

3285390000; colao@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: March 24, 2022
• Study Start: January 27, 2022
• Primary Completion: January 27, 2026
• Study Completion (Estimated): January 27, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)