SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-19

Study Completion Date

2025-05-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Testosterone Deficiency Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Collection of biological data

Intervention Type DIAGNOSTIC_TEST

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

Collection of biological data

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Collection of biological data

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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