SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

Recruiting

• Conditions: COVID-19; Infertility, Male; Testosterone Deficiency
• Interventions: Diagnostic Test: Collection of biological data

• Registration Number: NCT06177002
• Lead Sponsor: IRCCS San Raffaele

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 Timeline

• Study Start: 2020-05-19
• Status Verified: 2023-12
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-05-18
• Study Completion: 2025-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
male healthy individuals	Collection of biological data	Healthy donors with an age\> 18 accessing the IRCCS OSR Blood Donor Center
Male COVID-19 patients	Collection of biological data	Male patients with an age \> 18 affected by COVID-19 with biological samples positive for SARS-CoV-2 but with negative test

Primary Outcome Measures

Name	Time	Method
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy