Assessment of Diurnal Salivary Cortisol Production in COVID-19

NCT04988269 | Completed

• 1 other identifier: Ε.Σ 310
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; Adrenal Insufficiency; Adrenal Hyperfunction

Keywords

SARS-CoV-2 infection; Adrenal Cortex; Salivary Cortisol; Salivary DHEA; Aldosterone; ACTH; Interleukin 6; Circadian Rythm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  One day

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

  One day

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

  One day

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

  One day

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

  One Day

Study Arms (2)

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; 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).

Diagnostic Test: Blood sampling; Diagnostic Test: Saliva sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

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

Healthy Controls; Patients (Cases)

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.

Healthy Controls; Patients (Cases)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital based population. Patients with confirmed COVID-19

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Medical School, National and Kapodistrian University of Athens

Athens, 11527, Greece

Location

Related Publications (1)

• 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.

  PMID: 35043384 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and saliva samples

MeSH Terms

Conditions

COVID-19; Adrenal Insufficiency; Adrenocortical Hyperfunction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Endocrinology Consultant

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 3, 2021
• Study Start: April 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 28, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the day of publication and for 1 year.

Locations

GR (1)