COVID-19PROTEGGIMINCT06177002
SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY
An observational study of COVID-19 and Testosterone Deficiency, run by IRCCS San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Testosterone Deficiency, Infertility, Male
- What is being tested?
- Collection of biological data
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2020to 18 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male COVID-19 patients and male healthy individuals
Who may be able to join
- 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
Show all 9Show fewer
- Control Cohort:
- healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center;
- ability to read and sign the informed consent
Who cannot join
- People with an age < 18;
- incapacity to read and sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Andrea Salonia, MD, 02 2643 5661, salonia.andrea@hsr.it
About this study
Official 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.
Read the detailed 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.
- Conditions
- COVID-19, Testosterone Deficiency, Infertility, Male
- Being tested
- Collection of biological data
- Medical subject headings
- COVID-19, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological dataDiagnostic test
Biological sample will be collected from the COVID19 patients and from healthy donors
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Collection of biological data | |
| male healthy individuals | Healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center Receives: Diagnostic Test: Collection of biological data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start19 May 2020
- Primary completion18 May 2025 (estimated)
- Study completion18 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177002
- Sponsor's protocol ID
- PROTEGGIMI - 01/2020
- Acronym
- PROTEGGIMI
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT
- ClinicalTrials.gov ID
- NCT06177002
- Acronym / sponsor ID
- PROTEGGIMI / PROTEGGIMI - 01/2020
- Conditions
- COVID-19, Testosterone Deficiency, Infertility, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 18 May 2025 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male COVID-19 patients | – | Diagnostic Test: Collection of biological dataMale patients with an age > 18 affected by COVID-19 with biological samples positive for SARS-CoV-2 but with negative test |
| male healthy individuals | – | Diagnostic Test: Collection of biological dataHealthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male COVID-19 patients and male healthy individuals
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- People with an age < 18;
- incapacity to read and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological dataBiological sample will be collected from the COVID19 patients and from healthy donors | Diagnostic test | Male COVID-19 patients, male healthy individuals |
Primary outcome
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls
Time frame: Baseline
1 secondary outcome
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
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Testosterone Deficiency, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Maria Ferrara (0226437795, ferrara.annamaria@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of the androgenic hormonal environment in the blood of patients and healthy controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.