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Completed

NCT Number: NCT05749770

Hormonal Contributors to COVID-19 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.

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Key information

Conditions

COVID-19 Pandemic COVID-19 Coronaviridae Infections Coronavirus Infections Endocrine System Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

About this study

The objectives of the study are the following:

Primary objectives:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Testing

Other

blood testing for basal hormones and markers of inflammation

Other names: thyroid US scan in case of thyroid dysfunctions

Primary outcomes

  1. Endocrine function and markers of inflammation: TSH

    Time frame: through study completion, an average of 1 year

    Change in TSH (thyroid stimulating hormone), mU/L

  2. Endocrine function and markers of inflammation: IL-6

    Time frame: through study completion, an average of 1 year

    Change in IL-6 (interleukin-6), U/L

  3. Endocrine function and markers of inflammation: Testosterone

    Time frame: through study completion, an average of 1 year

    Change in total and free calculated testosterone, nmol/l

  4. Endocrine function and markers of inflammation: Cortisol

    Time frame: through study completion, an average of 1 year

    Change in cortisol, ug/dl

  5. Endocrine function and markers of inflammation: Reactive C-protein

    Time frame: through study completion, an average of 1 year

    Change in reactive C protein, mg/dl

  6. Endocrine function and markers of inflammation: ACTH

    Time frame: through study completion, an average of 1 year

    Change in ACTH (Adrenocorticotropic hormone), pg/ml

  7. Endocrine function and markers of inflammation: 25-OH vitamin D

    Time frame: through study completion, an average of 1 year

    Change in 25-OH vitamin D, ng/ml

  8. Prevalence of genetic variants of target genes

    Time frame: 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)

  9. Effect of vitamin D deficiency

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: COV-ENDO

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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