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临床试验/NCT04988269
NCT04988269已完成不适用

COVID-19, Interleukin - 6 and Diurnal Salivary Cortisol

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Diurnal variation of cortisol levels in the saliva (mcg/dL)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • (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.

结局指标

主要结局

Diurnal variation of cortisol levels in the saliva (mcg/dL)

时间窗: One day

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

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Yavropoulou

Senior Endocrinology Consultant

National and Kapodistrian University of Athens

研究点 (1)

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