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

Istituto Auxologico Italiano

Status: Completed

Conditions: Endocrine System Diseases; COVID-19 Pandemic

Treatments: Other: blood testing

Study type: Observational

Funder types: Other

Identifiers

NCT05749770

05C021

Details and patient eligibility

About

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.

Full description

The objectives of the study are the following:

Primary objectives:

1. 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.
2. 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.
3. to evaluate whether vitamin D supplementation in subjects with vitamin D deficiency may influence the outcome of SARs-CoV-2 infection
4. 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

220 participants in 2 patient groups

COVID-19

Description:

Patients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico

Treatment:

Other: blood testing

CONTROLS

Description:

440 NON-COVID subjects collected retrospectively at other collaborating centers) University of Siena, Campus Biomedico Rome, University of Catania, San Giovanni Rotondo)

Treatment:

Other: blood testing