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SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06177002
Acronym
PROTEGGIMI
Enrollment
2000
Registered
2023-12-20
Start date
2020-05-19
Completion date
2025-05-18
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Infertility, Male, Testosterone Deficiency

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.

Interventions

Biological sample will be collected from the COVID19 patients and from healthy donors

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Dosage of the androgenic hormonal environment in the blood of patients and healthy controlsBaseline

Secondary

MeasureTime frame
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 controlsBaseline

Countries

Italy

Contacts

Primary ContactAnna Maria Ferrara
ferrara.annamaria@hsr.it0226437795

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026