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

NCT05749770 | Completed

• 1 other identifier: 05C021
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

COVID-19 Pandemic; Endocrine System Diseases

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

COVID-19

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

Other: blood testing

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

Interventions

blood testing OTHER

blood testing for basal hormones and markers of inflammation

Also known as: thyroid US scan in case of thyroid dysfunctions

CONTROLS; COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Nasal swab positive for Sars-CoV-2
• Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.

You may not qualify if:

• History of thyroid diseases before admission
• History of adrenal diseases
• History of hypogonadism (primary/secondary)
• History of pituitary diseases

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

Related Publications (2)

• 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.

  PMID: 34126960 BACKGROUND

• 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.

  PMID: 33683214 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood and DNA samples

MeSH Terms

Conditions

COVID-19; Endocrine System Diseases

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Luca Persani, MD, PhD

  Istituto Auxologico Italiano IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 1, 2023
• Study Start: May 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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
• 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).

Locations

IT (1)