SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •People with an age < 18;
- •incapacity to read and sign the informed consent
Outcomes
Primary Outcomes
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
Time Frame: Baseline
Secondary Outcomes
- 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)
Investigators
Andrea Salonia
Prof
IRCCS San Raffaele