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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:
The objectives of the study are the following:
Primary objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 | Patients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico |
| |
| CONTROLS | 440 NON-COVID subjects collected retrospectively at other collaborating centers) University of Siena, Campus Biomedico Rome, University of Catania, San Giovanni Rotondo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood testing | Other | blood testing for basal hormones and markers of inflammation |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This is a pilot study aiming at evaluating all the subjects with COVID-19 admitted to the Istituto Auxologico during pandemic.
It is expected to recruit at least 220 COVID-19 subjects and 440 controls subjects collected retrospectively at the other centers.
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| Name | Affiliation | Role |
|---|---|---|
| Luca Persani, MD, PhD | Istituto Auxologico Italiano IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano IRCCS | Milan | 20145 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34126960 | Result | Campi I, Gennari L, Merlotti D, Mingiano C, Frosali A, Giovanelli L, Torlasco C, Pengo MF, Heilbron F, Soranna D, Zambon A, Di Stefano M, Aresta C, Bonomi M, Cangiano B, Favero V, Fatti L, Perego GB, Chiodini I, Parati G, Persani L. Vitamin D and COVID-19 severity and related mortality: a prospective study in Italy. BMC Infect Dis. 2021 Jun 14;21(1):566. doi: 10.1186/s12879-021-06281-7. | |
| 33683214 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Data obtained through this study may be provided to qualified researchers with academic interest in this topic. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access to individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Serum, whole blood and DNA samples
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 |
| Result |
| Campi I, Bulgarelli I, Dubini A, Perego GB, Tortorici E, Torlasco C, Torresani E, Rocco L, Persani L, Fugazzola L. The spectrum of thyroid function tests during hospitalization for SARS COV-2 infection. Eur J Endocrinol. 2021 May;184(5):699-709. doi: 10.1530/EJE-20-1391. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |