An observational study in COVID-19, Adrenal Insufficiency and Adrenal Hyperfunction, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by National and Kapodistrian University of Athens · Observational
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).
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 85 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Hospital based population. Patients with confirmed COVID-19
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.
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
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
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
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.
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).
Time frame: One day
Single hormone assessment of plasma ACTH levels (pg/mL)
Blood sampling was performed on the day of Hospital admission at one time point
Time frame: One day
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).
Time frame: One day
Single hormone assessment of plasma aldosterone levels (pmol/L)
Blood sampling was performed on the day of Hospital admission at one time point
Time frame: One day
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
Time frame: One day
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
Time frame: One Day
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens