Assessment of Diurnal Salivary Cortisol Production in COVID-19

Completed

• Conditions: Adrenal Hyperfunction; COVID-19; Adrenal Insufficiency
• Interventions: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva sampling

• Registration Number: NCT04988269
• Lead Sponsor: National and Kapodistrian University of Athens

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).

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 Timeline

• Study Start: 2021-04-15
• Status Verified: 2021-07
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-28
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-30
• Last Update Submitted: 2021-07-30
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients (Cases)	Saliva sampling	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).
Healthy Controls	Blood sampling	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).
Healthy Controls	Saliva sampling	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).
Patients (Cases)	Blood sampling	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Medical School, National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece