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Assessment of Diurnal Salivary Cortisol Production in COVID-19

COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04988269
Enrollment
85
Registered
2021-08-03
Start date
2021-04-15
Completion date
2021-07-28
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Adrenal Insufficiency, Adrenal Hyperfunction

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTBlood sampling

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

DIAGNOSTIC_TESTSaliva 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.

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diurnal variation of cortisol levels in the saliva (mcg/dL)One daySaliva sampling was performed at 4 different time points during one day (08.00, 12.00, 18.00, 22.00).

Secondary

MeasureTime frameDescription
Single hormone assessment of plasma ACTH levels (pg/mL)One dayBlood sampling was performed on the day of Hospital admission at one time point
Diurnal variation of dehydroepiandrosterone (DHEA) levels (pg/mL) in the salivaOne daySaliva 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 dayBlood sampling was performed on the day of Hospital admission at one time point
Single hormone assessment of serum Interleukin-6 levels (IL-6) (pg/mL)One dayBlood 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 DayBlood sampling was performed on the day of Hospital admission at one time point

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026