SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

NCT06177002 | Unknown

• 1 other identifier: PROTEGGIMI - 01/2020
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Testosterone Deficiency; Infertility, Male

Outcome Measures

Primary Outcomes (1)

• Dosage of the androgenic hormonal environment in the blood of patients and healthy controls

  Baseline

Secondary Outcomes (1)

• 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

Study Arms (2)

Male COVID-19 patients

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

Diagnostic Test: Collection of biological data

male healthy individuals

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

Diagnostic Test: Collection of biological data

Interventions

Collection of biological data DIAGNOSTIC_TEST

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

Male COVID-19 patients; male healthy individuals

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male COVID-19 patients and male healthy individuals

You may qualify if:

• 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

You may not qualify if:

• People with an age \< 18;
• incapacity to read and sign the informed consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Infertility, Male

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Central Study Contacts

Anna Maria Ferrara

CONTACT

0226437795; ferrara.annamaria@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: December 20, 2023
• Study Start: May 19, 2020
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)