SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI)

San Donato Group (GSD)

Status: Enrolling

Conditions: COVID-19; Testosterone Deficiency; Infertility, Male

Treatments: Diagnostic Test: Collection of biological data

Study type: Observational

Funder types: Other

Identifiers

NCT06177002

PROTEGGIMI - 01/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Male COVID-19 patients

Description:

Male patients with an age \> 18 affected by COVID-19 with biological samples positive for SARS-CoV-2 but with negative test

Treatment:

Diagnostic Test: Collection of biological data

male healthy individuals

Description:

Healthy donors with an age\> 18 accessing the IRCCS OSR Blood Donor Center

Treatment:

Diagnostic Test: Collection of biological data