Skip to main content
OpenTrials
Completed

NCT Number: NCT04988269

Assessment of Diurnal Salivary Cortisol Production in COVID-19

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Adrenal Gland Diseases Adrenal Hyperfunction Adrenal Insufficiency Adrenocortical Hyperfunction Coronaviridae Infections Coronavirus Infections Endocrine System Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical School, National and Kapodistrian University of Athens

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Diagnostic Test

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

saliva sampling

Diagnostic 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Single hormone assessment of plasma ACTH levels (pg/mL)

    Time frame: One day

    Blood sampling was performed on the day of Hospital admission at one time point

  2. Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the saliva

    Time frame: One day

    Saliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).

  3. Single hormone assessment of plasma aldosterone levels (pmol/L)

    Time frame: One day

    Blood sampling was performed on the day of Hospital admission at one time point

  4. Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL)

    Time frame: One day

    Blood sampling was performed on the day of Hospital admission at one time point

  5. Single hormone assessment of serum C-reactive protein levels (CRP) (mg/L)

    Time frame: One Day

    Blood sampling was performed on the day of Hospital admission at one time point

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.