SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

Study Overview
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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.

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.

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

Conditions
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Testosterone Deficiency, Infertility, Male, COVID-19

Intervention / Treatment
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* Diagnostic Test: Collection of biological data


Participation Criteria
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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 Exclusion Criteria: People with an age < 18; incapacity to read and sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male COVID-19 patients<br>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<br>* Biological sample will be collected from the COVID19 patients and from healthy donors<br>|
| male healthy individuals<br>Healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center | Diagnostic Test: Collection of biological data<br>* Biological sample will be collected from the COVID19 patients and from healthy donors<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |