Assessment of Diurnal Salivary Cortisol Production in COVID-19

COVID-19 Clinical Trial

Official title:

COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988269
• Other study ID #: ?.S 310
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: July 28, 2021

Study information

• Verified date: July 2021
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 28, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency
• COVID-19

Intervention

Diagnostic Test:
• Blood sampling
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
• 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.

Locations

Country	Name	City	State
Greece	Medical School, National and Kapodistrian University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One day
Secondary	Single hormone assessment of plasma ACTH levels (pg/mL)	Blood sampling was performed on the day of Hospital admission at one time point	One day
Secondary	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).	One day
Secondary	Single hormone assessment of plasma aldosterone levels (pmol/L)	Blood sampling was performed on the day of Hospital admission at one time point	One day
Secondary	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	One day
Secondary	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	One Day