SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
研究概览
简要总结
The hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection.
详细描述
Preliminary data suggests that male individuals are more susceptible to COVID-19 infection, at least in Western countries, and that their mortality rate is higher than female individuals. This would seem to suggest that the hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection. Another option is that COVID-19 infection could cause a condition of acute hypogonadism, following which, the exhaustion of androgenic action could act as a co-trigger of a severe or even fatal course of the disease.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Patient Cohort:
- •Male patients with an age > 18 hospitalized in the departments dedicated to the care of patients affected by COVID-19 at the San Raffaele Hospital and with:
- •biological samples positive for SARS-CoV-2;
- •negative test but highly suggestive clinical and radiological picture;
- •patients discharged from the emergency room with biological samples positive for SARS-CoV-2;
- •ability to read and sign the informed consent
- •Control Cohort:
- •healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center;
- •ability to read and sign the informed consent
排除标准
- •People with an age < 18;
- •incapacity to read and sign the informed consent
结局指标
主要结局
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
时间窗: Baseline
次要结局
- create an international (European) registry for the management of sensitive data in epidemiological terms and pathology outcomes relating to males with confirmed COVID-19 infection and age-matched healthy controls(Baseline)