Hormonal Contributors to Coronavirus SARS-CoV-2 Infection (COV-ENDO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Endocrine function and markers of inflammation: TSH
研究概览
简要总结
The goal of this observational study is to measure the changes in the parameters of endocrine function and tissue sensitivity to hormones induced by SARs-CoV-2 infection.
The main questions it aims to answer are:
- Does SARs-CoV-2 infection causes endocrine dysfunctions?
- Does the treatment of the underlying endocrine dysfunctions, improves the clinical outcome or the occurrence of late onset complications of SARs-CoV-2 infection?
- Are patients with previously known endocrine diseases more fragile in case of SARs-CoV-2 infection? Participants will undergo blood testing and a physical examination at admission, during hospitalization at discharge and 3 and 6 moths after discharge They results will be compared to those of patients admitted for other reasons in order to assess whether the prevalence of endocrine dysfunctions is increased compared with controls.
详细描述
The objectives of the study are the following:
Primary objectives:
- to measure endocrine function tests in patients affected by COVID-19, in order to evaluate whether SARs-CoV-2 causes endocrine alterations and whether endocrine diseases/dysfunctions correlate with the severity of SARs-CoV-2 infection and mortality.
- to evaluate whether genetic variants in the sex-steroid or vitamin D (VDR) nuclear receptors or ACE are more prevalent in patients with SARs-CoV-2 infection than controls.
- to evaluate whether vitamin D supplementation in subjects with vitamin D deficiency may influence the outcome of SARs-CoV-2 infection
- To correlate the influence of overweight/obesity/neck circumference with the evolution of SARs-CoV-2 infection
Secondary objectives:
Correlate the endocrine function tests with patients' age, disease's outcome, markers of inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Nasal swab positive for Sars-CoV-2
- •Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.
排除标准
- •History of thyroid diseases before admission
- •History of adrenal diseases
- •History of hypogonadism (primary/secondary)
- •History of pituitary diseases
结局指标
主要结局
Endocrine function and markers of inflammation: TSH
时间窗: through study completion, an average of 1 year
Change in TSH (thyroid stimulating hormone), mU/L
Endocrine function and markers of inflammation: Reactive C-protein
时间窗: through study completion, an average of 1 year
Change in reactive C protein, mg/dl
Endocrine function and markers of inflammation: 25-OH vitamin D
时间窗: through study completion, an average of 1 year
Change in 25-OH vitamin D, ng/ml
Effect of vitamin D deficiency
时间窗: through study completion, an average of 1 year
Assessment of the following parameters of clinical outcome: mortality, complication during hospitalization, complication after discharge, quality of life
Endocrine function and markers of inflammation: ACTH
时间窗: through study completion, an average of 1 year
Change in ACTH (Adrenocorticotropic hormone), pg/ml
Endocrine function and markers of inflammation: Cortisol
时间窗: through study completion, an average of 1 year
Change in cortisol, ug/dl
Endocrine function and markers of inflammation: IL-6
时间窗: through study completion, an average of 1 year
Change in IL-6 (interleukin-6), U/L
Endocrine function and markers of inflammation: Testosterone
时间窗: through study completion, an average of 1 year
Change in total and free calculated testosterone, nmol/l
Prevalence of genetic variants of target genes
时间窗: through study completion, an average of 1 year
NGS/direct sequence of androgen receptor (AR), progesterone receptor (PGR), estrogen receptors (ESR1 and 2), vitamin D receptor (VDR), Angiotensin-converting enzyme 2 (ACE2)
次要结局
未报告次要终点