Clinical trial NCT04988269: Assessment of Diurnal Salivary Cortisol Production in COVID-19
Official title: COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Adrenal Insufficiency
Adrenal Hyperfunction
Keywords: SARS-CoV-2 infection
Adrenal Cortex
Salivary Cortisol
Salivary DHEA
Aldosterone
ACTH
Interleukin 6
Circadian Rythm
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital based population. Patients with confirmed COVID-19

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diurnal variation of cortisol levels in the saliva (mcg/dL)
timeFrame: One day
Secondary outcomes:
measure: Single hormone assessment of plasma ACTH levels (pg/mL)
timeFrame: One day
measure: Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the saliva
timeFrame: One day
measure: Single hormone assessment of plasma aldosterone levels (pmol/L)
timeFrame: One day
measure: Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL)
timeFrame: One day
measure: Single hormone assessment of serum C-reactive protein levels (CRP) (mg/L)
timeFrame: One Day
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Medical School, National and Kapodistrian University of Athens
Study officials:
References:
citation: 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.