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

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

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.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases; COVID-19 Pandemic
• Intervention / Treatment: Other: blood testing

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20145
    • Istituto Auxologico Italiano IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: thyroid US scan in case of thyroid dysfunctions
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: thyroid US scan in case of thyroid dysfunctions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Luca Persani, MD, PhD, Istituto Auxologico Italiano IRCCS

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Endocrine System Diseases; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: 05C021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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
• IPD Sharing Access Criteria: 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).

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No