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

COVID-19 Pandemic Clinical Trial

— COV-ENDO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05749770
• Other study ID #: 05C021
• Status: Active, not recruiting
• Start date: May 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Endocrine System Diseases

Intervention

Other:
• blood testing
blood testing for basal hormones and markers of inflammation

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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: 10.1 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocrine function and markers of inflammation: TSH	Change in TSH (thyroid stimulating hormone), mU/L	through study completion, an average of 1 year
Primary	Endocrine function and markers of inflammation: IL-6	Change in IL-6 (interleukin-6), U/L	through study completion, an average of 1 year
Primary	Endocrine function and markers of inflammation: Testosterone	Change in total and free calculated testosterone, nmol/l	through study completion, an average of 1 year
Primary	Endocrine function and markers of inflammation: Cortisol	Change in cortisol, ug/dl	through study completion, an average of 1 year
Primary	Endocrine function and markers of inflammation: Reactive C-protein	Change in reactive C protein, mg/dl	through study completion, an average of 1 year
Primary	Endocrine function and markers of inflammation: ACTH	Change in ACTH (Adrenocorticotropic hormone), pg/ml	through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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