COVID-19 PandemicCOV-ENDONCT05749770
Hormonal Contributors to COVID-19 Infection (COV-ENDO)
An observational study of COVID-19 Pandemic and Endocrine System Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic, Endocrine System Diseases
- What is being tested?
- blood testing
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Nasal swab positive for Sars-CoV-2
- Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.
Who cannot join
- History of thyroid diseases before admission
- History of adrenal diseases
- History of hypogonadism (primary/secondary)
- History of pituitary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- COVID-19 Pandemic, Endocrine System Diseases
- Being tested
- blood testing
- Medical subject headings
- COVID-19, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testingOther
Also called thyroid US scan in case of thyroid dysfunctions
blood testing for basal hormones and markers of inflammation
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico Receives: 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) Receives: Other: blood testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine function and markers of inflammation: TSH
Change in TSH (thyroid stimulating hormone), mU/L
Measured: through study completion, an average of 1 year
Endocrine function and markers of inflammation: IL-6
Change in IL-6 (interleukin-6), U/L
Measured: through study completion, an average of 1 year
Endocrine function and markers of inflammation: Testosterone
Change in total and free calculated testosterone, nmol/l
Measured: through study completion, an average of 1 year
Endocrine function and markers of inflammation: Cortisol
Change in cortisol, ug/dl
Measured: through study completion, an average of 1 year
Endocrine function and markers of inflammation: Reactive C-protein
Change in reactive C protein, mg/dl
Measured: through study completion, an average of 1 year
Endocrine function and markers of inflammation: ACTH
Change in ACTH (Adrenocorticotropic hormone), pg/ml
Measured: 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
Measured: 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)
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 May 2020
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Persani, MD, PhD, Principal investigator, Istituto Auxologico Italiano IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749770
- Sponsor's protocol ID
- 05C021
- Acronym
- COV-ENDO
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34126960Campi 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.
PubMed 33683214
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Contributors to Coronavirus SARS-CoV-2 Infection (COV-ENDO)
- ClinicalTrials.gov ID
- NCT05749770
- Acronym / sponsor ID
- COV-ENDO / 05C021
- Conditions
- COVID-19 Pandemic, Endocrine System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: blood testingPatients affected with SARs-CoV-2 infection and hospitalized in the COVID wards of Auxologico |
| CONTROLS | – | Other: blood testing440 NON-COVID subjects collected retrospectively at other collaborating centers) University of Siena, Campus Biomedico Rome, University of Catania, San Giovanni Rotondo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Nasal swab positive for Sars-CoV-2
- Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.
Key exclusion criteria (4 listed)
- History of thyroid diseases before admission
- History of adrenal diseases
- History of hypogonadism (primary/secondary)
- History of pituitary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testingAlso: thyroid US scan in case of thyroid dysfunctionsblood testing for basal hormones and markers of inflammation | Other | CONTROLS, COVID-19 |
Primary outcome
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
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
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
Endocrine function and markers of inflammation: Cortisol
Time frame: through study completion, an average of 1 year
Change in cortisol, ug/dl
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
Endocrine function and markers of inflammation: ACTH
Time frame: through study completion, an average of 1 year
Change in ACTH (Adrenocorticotropic hormone), pg/ml
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 34126960Campi 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.
- Results publication: PubMed 33683214Campi 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Persani, MD, PhD principal investigator
Istituto Auxologico Italiano IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Endocrine System Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocrine function and markers of inflammation: TSH (time frame: through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.