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

March 23, 2022 updated by: Annamaria Colao, Federico II University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Annamaria Colao, Prof
  • Phone Number: 3285390000
  • Email: colao@unina.it

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • Federico II University of Naples
        • Contact:
          • Annamaria Colao, Prof
          • Phone Number: 3285390000
          • Email: colao@unina.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Change from baseline at 3-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid dysfunctions
Time Frame: Change from baseline at 3-12 months
Prevalence of thyroid dysfunctions (hypo, hyper functions; thyroiditis)
Change from baseline at 3-12 months
Female gonadal dysfunctions
Time Frame: Change from baseline at 3-12 months
Prevalence of female gonadal dysfunctions (hypogonadism and female sexual dysfunctions)
Change from baseline at 3-12 months
Adrenal dysfunctions
Time Frame: Change from baseline at 3-12 months
Prevalence of adrenal dysfunctions (hypocortisolism)
Change from baseline at 3-12 months
Pituitary dysfunctions
Time Frame: Change from baseline at 3-12 months
Prevalence of pituitary dysfunctions (hyperprolactinemia, GH deficiency)
Change from baseline at 3-12 months
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)
Change from baseline at 3-12 months
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
Change from baseline at 3-12 months
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.
Change from baseline at 3-12 months
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)
Change from baseline at 3-12 months
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
Change from baseline at 3-12 months
Post-thrombotic vascular dysfunctions
Time Frame: Change from baseline at 3-12 months
Prevalence of previously unknown deep venous thrombosis
Change from baseline at 3-12 months
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.
Change from baseline at 3-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

Azienda Sanitaria Locale Napoli 2 Nord

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2022

Primary Completion (ANTICIPATED)

January 27, 2024

Study Completion (ANTICIPATED)

January 27, 2024

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (ACTUAL)

March 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LO-COCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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