Exploring the link between testosterone levels and COVID-19 in men
SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT
IRCCS San Raffaele · NCT06177002
This study is trying to see if low testosterone levels make men more likely to get seriously ill from COVID-19.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06177002 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between testosterone levels and susceptibility to COVID-19 in male patients. It aims to collect biological data from hospitalized male patients who have tested positive for SARS-CoV-2, as well as from healthy male donors. The study seeks to understand whether testosterone deficiency may contribute to increased vulnerability and severe outcomes in men infected with the virus. By analyzing these hormonal factors, the research hopes to shed light on potential pathophysiological mechanisms involved in COVID-19 severity among males.
Who should consider this trial
Good fit: Ideal candidates include male patients over 18 years old who are hospitalized with COVID-19 or healthy male donors over 18 years old.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how testosterone levels affect COVID-19 outcomes in men, potentially guiding treatment strategies.
How similar studies have performed: While the specific relationship between testosterone and COVID-19 is still being explored, preliminary data suggests that hormonal factors may influence disease severity, indicating a novel area of investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Lombardy
- IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy (RECRUITING)
Study contacts
- Study coordinator: Anna Maria Ferrara
- Email: ferrara.annamaria@hsr.it
- Phone: 0226437795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COVID-19, Testosterone Deficiency, Infertility, Male