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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Infertility, Male; Testosterone Deficiency
• Intervention / Treatment: Diagnostic test: Collection of biological data

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Anna Maria Ferrara; Phone Number: 0226437795; Email: ferrara.annamaria@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Andrea Salonia, MD; Phone Number: 02 2643 5661; Email: salonia.andrea@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male COVID-19 patients and male healthy individuals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Biological sample will be collected from the COVID19 patients and from healthy donors
male healthy individuals; Healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center	Diagnostic test: Collection of biological data; Biological sample will be collected from the COVID19 patients and from healthy donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls	Baseline

Secondary Outcome Measures

Outcome Measure	Time 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 controls	Baseline

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Estimated): May 18, 2025
• Study Completion (Estimated): May 18, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: PROTEGGIMI - 01/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No