Hormonal Contributors to COVID-19 Infection (COV-ENDO)

Study Overview
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Brief Summary
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The goal of this observational study is to measure the changes in the parameters of endocrine function and tissue sensitivity to hormones induced by SARs-CoV-2 infection. The main questions it aims to answer are: Does SARs-CoV-2 infection causes endocrine dysfunctions? Does the treatment of the underlying endocrine dysfunctions, improves the clinical outcome or the occurrence of late onset complications of SARs-CoV-2 infection? Are patients with previously known endocrine diseases more fragile in case of SARs-CoV-2 infection? Participants will undergo blood testing and a physical examination at admission, during hospitalization at discharge and 3 and 6 moths after discharge They results will be compared to those of patients admitted for other reasons in order to assess whether the prevalence of endocrine dysfunctions is increased compared with controls.

Detailed Description
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The objectives of the study are the following: Primary objectives: to measure endocrine function tests in patients affected by COVID-19, in order to evaluate whether SARs-CoV-2 causes endocrine alterations and whether endocrine diseases/dysfunctions correlate with the severity of SARs-CoV-2 infection and mortality. to evaluate whether genetic variants in the sex-steroid or vitamin D (VDR) nuclear receptors or ACE are more prevalent in patients with SARs-CoV-2 infection than controls. to evaluate whether vitamin D supplementation in subjects with vitamin D deficiency may influence the outcome of SARs-CoV-2 infection To correlate the influence of overweight/obesity/neck circumference with the evolution of SARs-CoV-2 infection Secondary objectives: Correlate the endocrine function tests with patients' age, disease's outcome, markers of inflammation. The identification of endocrine conditions associated with a worse outcome of SARs-CoV-2 infection, would identify significant risk factors to be reduced/prevented in these patients. For example, if endocrine patients will result more fragile in case of infection, we could systematically screen some parameters and early treat associated defects in order improve the outcome of SARs-CoV-2 infection.

Official Title
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Hormonal Contributors to Coronavirus SARS-CoV-2 Infection (COV-ENDO)

Conditions
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COVID-19 Pandemic, Endocrine System Diseases

Intervention / Treatment
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* Other: blood testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nasal swab positive for Sars-CoV-2 Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization. Exclusion Criteria: History of thyroid diseases before admission History of adrenal diseases History of hypogonadism (primary/secondary) History of pituitary diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Patients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico | Other: blood testing<br>* blood testing for basal hormones and markers of inflammation<br>* Other names: thyroid US scan in case of thyroid dysfunctions;|
| CONTROLS<br>440 NON-COVID subjects collected retrospectively at other collaborating centers) University of Siena, Campus Biomedico Rome, University of Catania, San Giovanni Rotondo) | Other: blood testing<br>* blood testing for basal hormones and markers of inflammation<br>* Other names: thyroid US scan in case of thyroid dysfunctions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine function and markers of inflammation: TSH | Change in TSH (thyroid stimulating hormone), mU/L | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: IL-6 | Change in IL-6 (interleukin-6), U/L | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: Testosterone | Change in total and free calculated testosterone, nmol/l | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: Cortisol | Change in cortisol, ug/dl | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: Reactive C-protein | Change in reactive C protein, mg/dl | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: ACTH | Change in ACTH (Adrenocorticotropic hormone), pg/ml | through study completion, an average of 1 year | 
| Endocrine function and markers of inflammation: 25-OH vitamin D | Change in 25-OH vitamin D, ng/ml | through study completion, an average of 1 year | 
| Prevalence of genetic variants of target genes | NGS/direct sequence of androgen receptor (AR), progesterone receptor (PGR), estrogen receptors (ESR1 and 2), vitamin D receptor (VDR), Angiotensin-converting enzyme 2 (ACE2) | through study completion, an average of 1 year | 
| Effect of vitamin D deficiency | Assessment of the following parameters of clinical outcome: mortality, complication during hospitalization, complication after discharge, quality of life | through study completion, an average of 1 year |