Hormonal Contributors to COVID-19 Infection (COV-ENDO)
Study Details
Study Description
Brief Summary
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:
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Does SARs-CoV-2 infection causes endocrine dysfunctions?
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Does the treatment of the underlying endocrine dysfunctions, improves the clinical outcome or the occurrence of late onset complications of SARs-CoV-2 infection?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The objectives of the study are the following:
Primary objectives:
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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.
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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.
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to evaluate whether vitamin D supplementation in subjects with vitamin D deficiency may influence the outcome of SARs-CoV-2 infection
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 Patients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico |
Other: blood testing
blood testing for basal hormones and markers of inflammation
Other Names:
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| CONTROLS 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
blood testing for basal hormones and markers of inflammation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Endocrine function and markers of inflammation: TSH [through study completion, an average of 1 year]
Change in TSH (thyroid stimulating hormone), mU/L
- Endocrine function and markers of inflammation: IL-6 [through study completion, an average of 1 year]
Change in IL-6 (interleukin-6), U/L
- Endocrine function and markers of inflammation: Testosterone [through study completion, an average of 1 year]
Change in total and free calculated testosterone, nmol/l
- Endocrine function and markers of inflammation: Cortisol [through study completion, an average of 1 year]
Change in cortisol, ug/dl
- Endocrine function and markers of inflammation: Reactive C-protein [through study completion, an average of 1 year]
Change in reactive C protein, mg/dl
- Endocrine function and markers of inflammation: ACTH [through study completion, an average of 1 year]
Change in ACTH (Adrenocorticotropic hormone), pg/ml
- Endocrine function and markers of inflammation: 25-OH vitamin D [through study completion, an average of 1 year]
Change in 25-OH vitamin D, ng/ml
- Prevalence of genetic variants of target genes [through study completion, an average of 1 year]
NGS/direct sequence of androgen receptor (AR), progesterone receptor (PGR), estrogen receptors (ESR1 and 2), vitamin D receptor (VDR), Angiotensin-converting enzyme 2 (ACE2)
- Effect of vitamin D deficiency [through study completion, an average of 1 year]
Assessment of the following parameters of clinical outcome: mortality, complication during hospitalization, complication after discharge, quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
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Nasal swab positive for Sars-CoV-2
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Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.
Exclusion Criteria:
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History of thyroid diseases before admission
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History of adrenal diseases
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History of hypogonadism (primary/secondary)
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History of pituitary diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Auxologico Italiano IRCCS | Milan | Italy | 20145 |
Sponsors and Collaborators
- Istituto Auxologico Italiano
Investigators
- Principal Investigator: Luca Persani, MD, PhD, Istituto Auxologico Italiano IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05C021