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

Sponsor
Federico II University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05293366
Collaborator
Azienda Sanitaria Locale Napoli 2 Nord (Other)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Assessments of endocrinological phenotypes of LO-COCO patients
  • Diagnostic Test: Assessment of muscular phenotypes of LO-COCO patients
  • Diagnostic Test: Assessment of neuropsychiatric phenotypes of LO-COCO patients
  • Procedure: Muscle biopsy
  • Diagnostic Test: Assessment of pulmonary phenotypes of LO-COCO patients
  • Diagnostic Test: Assessment of cardiological phenotypes of LO-COCO patients
  • Diagnostic Test: Assessment of vascular phenotypes of LO-COCO patients
  • Diagnostic Test: Assessment of dermatological phenotypes of LO-COCO patients
  • Procedure: Tissue biopsy

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions
Actual Study Start Date :
Jan 27, 2022
Anticipated Primary Completion Date :
Jan 27, 2024
Anticipated Study Completion Date :
Jan 27, 2024

Outcome Measures

Primary Outcome Measures

  1. 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]

    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 Outcome Measures

  1. Thyroid dysfunctions [Change from baseline at 3-12 months]

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

  2. Female gonadal dysfunctions [Change from baseline at 3-12 months]

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

  3. Adrenal dysfunctions [Change from baseline at 3-12 months]

    Prevalence of adrenal dysfunctions (hypocortisolism)

  4. Pituitary dysfunctions [Change from baseline at 3-12 months]

    Prevalence of pituitary dysfunctions (hyperprolactinemia, GH deficiency)

  5. Metabolic dysfunctions [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 [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 [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 [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 [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 [Change from baseline at 3-12 months]

    Prevalence of previously unknown deep venous thrombosis

  11. Dermatological dysfunctions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federico II University of Naples Naples Italy 80131

Sponsors and Collaborators

  • Federico II University
  • Azienda Sanitaria Locale Napoli 2 Nord

Investigators

  • Principal Investigator: Annamaria Colao, Prof, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Annamaria Colao, Clinical Professor, Federico II University
ClinicalTrials.gov Identifier:
NCT05293366
Other Study ID Numbers:
  • LO-COCO
First Posted:
Mar 24, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Annamaria Colao, Clinical Professor, Federico II University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022