COVID-19 Clinical Trial
— PROTEGGIMIOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale San Raffaele | Milan | Lombardy |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
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 |
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