COVID-19NCT04988269
Assessment of Diurnal Salivary Cortisol Production in COVID-19
An observational study of COVID-19 and Adrenal Insufficiency, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
In the year of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic several studies have focused on the effect of the COVID-19 on the adrenal cortex, demonstrating conflicting results. 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, Adrenal Insufficiency, Adrenal Hyperfunction
- What is being tested?
- Blood sampling and Saliva sampling
- How many people
- 85 participants
- Where
- 1 siteGreece
- Study dates
- 15 Apr 2021to 28 Jul 2021
- 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: Hospital based population. Patients with confirmed COVID-19
Who may be able to join
- Adult patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology
Who cannot join
- pre-existing hypoadrenalism or concurrent systemic glucocorticoid treatment (ii) patients with chronic kidney disease stage 3b and above, (iii) patients with advanced metastatic disease.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Medical School, National and Kapodistrian University of Athens
Athens, 11527
About this study
Official title: COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol
In the year of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic several studies have focused on the effect of the COVID-19 on the adrenal cortex, demonstrating conflicting results. Herein, researchers sought to investigate the adrenal response in patients with COVID-19by assessing the diurnal rhythm of salivary cortisol and the adrenal androgen dehydroepiandrosterone (DHEA), as well as the plasma levels of aldosterone and adrenocorticotropic hormone (ACTH) in consecutive patients before the possible therapeutic administration of dexamethasone. To elucidate the potential association between the magnitude of individual immune response and the adrenal cortex response we included serum measurements of interleukin - 6 (IL-6).
Read the detailed description
All adult consecutive patients that visited the emergency department of the LAIKO General Hospital of Athens from May to July 2021 due to confirmed COVID-19 and related symptomatology were eligible for the study.
Age and gender matched healthy individuals without COVID-19 who had never been treated with GCs and fulfilled the exclusion criteria were also recruited from the Hospital's personnel and included in the analysis as Controls.
Blood samples were obtained immediately upon admission for the measurements of ACTH, IL-6 and aldosterone, which were performed by electrochemiluminescence assays on the cobas e 801 immunoassay analysers (Roche Diagnostics GmbH). Salivary samples for free cortisol and DHEAS were obtained during the next day using the Salivette (Sarstedt, Nümbrecht, Germany) at different time points 0800, 12.00, 18.00, and 22.00. Within 24h after saliva collection the salivettes were centrifuged at 2400 g for 20 min in 4 °C and aliquots were stored at -80 °C and analyzed by an Immunochemiluminescence assay in a Roche COBAS E411 analyzer.
- Conditions
- COVID-19, Adrenal Insufficiency, Adrenal Hyperfunction
- Being tested
- Blood sampling, Saliva sampling
- Keywords
- SARS-CoV-2 infection, Adrenal Cortex, Salivary Cortisol, Salivary DHEA, Aldosterone, ACTH, Interleukin 6, Circadian Rythm
- Medical subject headings
- COVID-19, Adrenal Insufficiency, Adrenocortical Hyperfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
Saliva samplingDiagnostic test
Assessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2.
| Study group | Role | What they receive |
|---|---|---|
| Patients (Cases) | Adult consecutive patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology.
Blood sampling on the day of admission (one time point) and saliva sampling at 4 different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day). Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva sampling | |
| Healthy Controls | Age and gender matched healthy individuals without COVID-19. Blood sampling (at day 1) and saliva sampling at different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day-day 2). Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal variation of cortisol levels in the saliva (mcg/dL)
Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).
Measured: One day
Secondary outcomes (5)
Single hormone assessment of plasma ACTH levels (pg/mL)
Blood sampling was performed on the day of Hospital admission at one time point
Measured: One day
Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the saliva
Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).
Measured: One day
Single hormone assessment of plasma aldosterone levels (pmol/L)
Blood sampling was performed on the day of Hospital admission at one time point
Measured: One day
Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL)
Blood sampling was performed on the day of Hospital admission at one time point
Measured: One day
Single hormone assessment of serum C-reactive protein levels (CRP) (mg/L)
Blood sampling was performed on the day of Hospital admission at one time point
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start15 Apr 2021
- Primary completion15 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Yavropoulou, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988269
- Sponsor's protocol ID
- Ε.Σ 310
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Yavropoulou MP, Filippa MG, Mantzou A, Ntziora F, Mylona M, Tektonidou MG, Vlachogiannis NI, Paraskevis D, Kaltsas GA, Chrousos GP, Sfikakis PP. Alterations in cortisol and interleukin-6 secretion in patients with COVID-19 suggestive of neuroendocrine-immune adaptations. Endocrine. 2022 Feb;75(2):317-327. doi: 10.1007/s12020-021-02968-8. Epub 2022 Jan 18.
PubMed 35043384
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol
- ClinicalTrials.gov ID
- NCT04988269
- Acronym / sponsor ID
- Ε.Σ 310
- Conditions
- COVID-19, Adrenal Insufficiency, Adrenal Hyperfunction
- Keywords
- SARS-CoV-2 infection, Adrenal Cortex, Salivary Cortisol, Salivary DHEA, Aldosterone, ACTH, Interleukin 6, Circadian Rythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 3 Aug 2021 (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.
In the year of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic several studies have focused on the effect of the COVID-19 on the adrenal cortex, demonstrating conflicting results. Herein, researchers sought to investigate the adrenal response in patients with COVID-19by assessing the diurnal rhythm of salivary cortisol and the adrenal androgen dehydroepiandrosterone (DHEA), as well as the plasma levels of aldosterone and adrenocorticotropic hormone (ACTH) in consecutive patients before the possible therapeutic administration of dexamethasone. To elucidate the potential association between the magnitude of individual immune response and the adrenal cortex response we included serum measurements of interleukin - 6 (IL-6).
Detailed description
All adult consecutive patients that visited the emergency department of the LAIKO General Hospital of Athens from May to July 2021 due to confirmed COVID-19 and related symptomatology were eligible for the study.
Age and gender matched healthy individuals without COVID-19 who had never been treated with GCs and fulfilled the exclusion criteria were also recruited from the Hospital's personnel and included in the analysis as Controls.
Blood samples were obtained immediately upon admission for the measurements of ACTH, IL-6 and aldosterone, which were performed by electrochemiluminescence assays on the cobas e 801 immunoassay analysers (Roche Diagnostics GmbH). Salivary samples for free cortisol and DHEAS were obtained during the next day using the Salivette (Sarstedt, Nümbrecht, Germany) at different time points 0800, 12.00, 18.00, and 22.00. Within 24h after saliva collection the salivettes were centrifuged at 2400 g for 20 min in 4 °C and aliquots were stored at -80 °C and analyzed by an Immunochemiluminescence assay in a Roche COBAS E411 analyzer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients (Cases) | – | Diagnostic Test: Blood sampling, Diagnostic Test: Saliva samplingAdult consecutive patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology. Blood sampling on the day of admission (one time point) and saliva sampling at 4 different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day). |
| Healthy Controls | – | Diagnostic Test: Blood sampling, Diagnostic Test: Saliva samplingAge and gender matched healthy individuals without COVID-19. Blood sampling (at day 1) and saliva sampling at different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day-day 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital based population. Patients with confirmed COVID-19
Key inclusion criteria (1 listed)
- Adult patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology
Key exclusion criteria (1 listed)
- pre-existing hypoadrenalism or concurrent systemic glucocorticoid treatment (ii) patients with chronic kidney disease stage 3b and above, (iii) patients with advanced metastatic disease.
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 samplingAssessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1 | Diagnostic test | Healthy Controls, Patients (Cases) |
| Saliva samplingAssessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2. | Diagnostic test | Healthy Controls, Patients (Cases) |
Primary outcome
Diurnal variation of cortisol levels in the saliva (mcg/dL)
Time frame: One day
Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).
5 secondary outcomes
Single hormone assessment of plasma ACTH levels (pg/mL)
Time frame: One day
Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the saliva
Time frame: One day
Single hormone assessment of plasma aldosterone levels (pmol/L)
Time frame: One day
Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL)
Time frame: One day
Single hormone assessment of serum C-reactive protein levels (CRP) (mg/L)
Time frame: One Day
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 3 Aug 2021.
- Derived from this study: PubMed 35043384Yavropoulou MP, Filippa MG, Mantzou A, Ntziora F, Mylona M, Tektonidou MG, Vlachogiannis NI, Paraskevis D, Kaltsas GA, Chrousos GP, Sfikakis PP. Alterations in cortisol and interleukin-6 secretion in patients with COVID-19 suggestive of neuroendocrine-immune adaptations. Endocrine. 2022 Feb;75(2):317-327. doi: 10.1007/s12020-021-02968-8. Epub 2022 Jan 18.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Adrenal Insufficiency, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 inclusion and 1 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 3 Aug 2021. 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 Greece. 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?
Diurnal variation of cortisol levels in the saliva (mcg/dL) (time frame: One day). 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 NCT04988269, which also lists 1 linked publication.
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 3 Aug 2021.