Clinical trial NCT05749770: Hormonal Contributors to COVID-19 Infection (COV-ENDO)
Official title: Hormonal Contributors to Coronavirus SARS-CoV-2 Infection (COV-ENDO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Endocrine System Diseases
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endocrine function and markers of inflammation: TSH
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: IL-6
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: Testosterone
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: Cortisol
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: Reactive C-protein
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: ACTH
timeFrame: through study completion, an average of 1 year
measure: Endocrine function and markers of inflammation: 25-OH vitamin D
timeFrame: through study completion, an average of 1 year
measure: Prevalence of genetic variants of target genes
timeFrame: through study completion, an average of 1 year
measure: Effect of vitamin D deficiency
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
affiliation: Istituto Auxologico Italiano IRCCS
name: Luca Persani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.