SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

COVID-19 Clinical Trial

— PROTEGGIMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177002
• Other study ID #: PROTEGGIMI - 01/2020
• Status: Recruiting
• Start date: May 19, 2020
• Est. completion date: May 18, 2025

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Anna Maria Ferrara
• Phone: 0226437795
• Email: ferrara.annamaria[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 18, 2025
• Est. primary completion date: May 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infertility
• Infertility, Male
• Testosterone Deficiency

Intervention

Diagnostic Test:
• Collection of biological data
Biological sample will be collected from the COVID19 patients and from healthy donors

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of the androgenic hormonal environment in the blood of patients and healthy controls		Baseline
Secondary	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