Clinical trial NCT05293366: LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions
Official title: LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long Covid-19
Keywords: Long Covid-19
Endocrine Complications
Metabolic Complications
Neuropsychiatric Complications
Muscular Complications
Cardiovascular Complications
Pulmonary Complications
Dermatologic Complications
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Locale Napoli 2 Nord
First posted: 2022-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients of both sexes recovered from SARS-CoV-2 infection

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Thyroid dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Female gonadal dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Adrenal dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Pituitary dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Metabolic dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Neuro-psychiatric dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Muscle dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Pulmonary dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Cardiological dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Post-thrombotic vascular dysfunctions
timeFrame: Change from baseline at 3-12 months
measure: Dermatological dysfunctions
timeFrame: Change from baseline at 3-12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University of Naples
Study officials:
affiliation: Federico II University
name: Annamaria Colao, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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