Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05293366

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

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.

Recruiting

Interested in participating?

Request Info

Key information

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: 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.

Primary outcomes

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

    Time frame: Change from baseline at 3-12 months

    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 .

Secondary outcomes

  1. Thyroid dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of thyroid dysfunctions (hypo, hyper functions; thyroiditis)

  2. Female gonadal dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of female gonadal dysfunctions (hypogonadism and female sexual dysfunctions)

  3. Adrenal dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of adrenal dysfunctions (hypocortisolism)

  4. Pituitary dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of pituitary dysfunctions (hyperprolactinemia, GH deficiency)

  5. Metabolic dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of metabolic dysfunctions (metabolic syndrome, type 2 diabetes, overweight, obesity, insulin-resistance, dyslipidemia, hypovitaminosis D)

  6. Neuro-psychiatric dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of depression, alteration of the quality of life, apathy, anxiety, deficit of attentional and cognitive skills

  7. Muscle dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of fatigue, reduced resistance and muscle strength, reduced muscle power, reduced exercise tolerance, myopathy.

  8. Pulmonary dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of persisting respiratory discomfort in relation to lung function and radiological outcomes (interstitial/organized pneumonia, pulmonary fibrosis)

  9. Cardiological dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of echocardiographic changes at rest and during echocardiogram stress tests, dysfunctions in cardiopulmonary performance

  10. Post-thrombotic vascular dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of previously unknown deep venous thrombosis

  11. Dermatological dysfunctions

    Time frame: Change from baseline at 3-12 months

    Prevalence of cutaneous and mucosal lesions, defluvium with identification of specific trichoscopic patterns and onychopathies with identification of specific onychoscopic/capillaroscopic patterns.

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Colao, Prof

CONTACT

[email protected]

3285390000

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

Registry information

Official study title

LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions

Acronym: LO-COCO

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.