An Exploratory Analysis of the Expression of Receptors and Activating Proteases Mediating SARS-CoV-2 Entry and the Association Between HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Expression of receptors and activating proteases
研究概览
简要总结
The study includes 2 sub-projects.
Sub-project 1: The aim is to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino.
Sub-project 2: The aim is to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino.
详细描述
Sub-project 1:
This is an observational retrospective study that aims to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino. The level of expression of these factors will be compared between infected and non-infected subjects. The sub-project will examine RNA samples from nasopharyngeal swabs taken from subjects tested for COVID-19.
Sub-project 2:
This is a haplotype- and diplotype-based case-control retrospective study that aims to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino. The gene status of HSD3B1 will be defined and compared between two groups of patients: the patients who experienced a severe SARS-CoV-2 infection (severe pulmonary insufficiency, ICU admission, eventually death) and the group with a mild-moderate COVID-19 disease without pulmonary insufficiency and oxygen need.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of RNA extracted from nasopharyngeal swabs taken from subjects tested for COVID-19;
- •Subject is aged 18 years or over;
- •Written informed consent (for SARS-CoV-2 positive patients only; see §5 for further details).
排除标准
- •Documented refusal.
- •Sub-project 2
- •Inclusion Criteria:
- •Female and male hospitalized SARS-CoV-2 patients;
- •Patient is aged 18 years or over;
- •Availability of archival tissue samples collected at any time before SARS-CoV-2 infection for any clinical reason;
- •Clinico-pathological characteristics of the COVID-19 and clinical outcomes recorded in the EOC and Clinica Luganese Moncucco database;
- •Written informed consent (see §5 for further details).
- •Exclusion Criteria:
- •Documented refusal.
结局指标
主要结局
Expression of receptors and activating proteases
时间窗: 1 year
Determination of the level of expression of the mRNA genes
Prevalencen of olymorphisms of the HSD3B1
时间窗: 1 year
Determination of the prevalence of polymorphisms of the HSD3B1 patients with severe and mild-moderate SARS-CoV-2 infection
Association of polymorphisms of the HSD3B1
时间窗: 1 year
Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters
次要结局
未报告次要终点
研究者
Ricardo Pereira Mestre
MD
Oncology Institute of Southern Switzerland