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临床试验/NCT06177002
NCT06177002招募中不适用

SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年5月19日最近更新:
适应症

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

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)

研究者

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

Andrea Salonia

Prof

IRCCS San Raffaele

研究点 (1)

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