Assessment of Diurnal Salivary Cortisol Production in COVID-19

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT04988269

Collaborator

(none)

Enrollment

Location

3.4

Actual Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Adrenal Insufficiency Adrenal Hyperfunction	Diagnostic Test: Blood sampling Diagnostic Test: Saliva sampling

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

Study Type:

Observational

Actual Enrollment :

85 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol

Actual Study Start Date :

Apr 15, 2021

Actual Primary Completion Date :

Jul 15, 2021

Actual Study Completion Date :

Jul 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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).	Diagnostic Test: Blood sampling Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1 Diagnostic Test: Saliva sampling 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.
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).	Diagnostic Test: Blood sampling Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1 Diagnostic Test: Saliva sampling 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.

Arm

Intervention/Treatment

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).

Diagnostic Test: Blood sampling

Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1

Diagnostic Test: Saliva sampling

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.

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).

Diagnostic Test: Blood sampling

Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1

Diagnostic Test: Saliva sampling

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.

Outcome Measures

Primary Outcome Measures

Diurnal variation of cortisol levels in the saliva (mcg/dL) [One day]
Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).

Secondary Outcome Measures

Single hormone assessment of plasma ACTH levels (pg/mL) [One day]
Blood sampling was performed on the day of Hospital admission at one time point
Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the saliva [One day]
Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).
Single hormone assessment of plasma aldosterone levels (pmol/L) [One day]
Blood sampling was performed on the day of Hospital admission at one time point
Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL) [One day]
Blood sampling was performed on the day of Hospital admission at one time point
Single hormone assessment of serum C-reactive protein levels (CRP) (mg/L) [One Day]
Blood sampling was performed on the day of Hospital admission at one time point

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

(i) pre-existing hypoadrenalism or concurrent systemic glucocorticoid treatment (ii) patients with chronic kidney disease stage 3b and above, (iii) patients with advanced metastatic disease.