SARS-CoV 2NCT04446169
COVID-19 (SARS-CoV-2) in Urine and Semen
An observational study of SARS-CoV 2 and Sexual Function and Fertility Disorders, run by University of Florence at 1 site in Italy.
Trial summary
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- SARS-CoV 2, Sexual Function and Fertility Disorders, Urinary Function Disorders
- What is being tested?
- SARS-CoV 2 RNA PCR Urine, SARS-CoV 2 RNA PCR Semen and Semen Qualitative Analysis
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2020to 2 Sep 2021
- 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 to 80 years
- Men only
- Adult, Older adult
Study population: Prospective cohort study on male patients with a documented previous infection for SARS-CoV2, including symptomatic and asymptomatic patients.Patients need to be eligible for the inclusion criteria and to sign the informed consent to be enrolled to the study
Who may be able to join
- Male Sex
- Age>18 years
- Will to participate to the study
- Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA)
- Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)
Who cannot join
- Age more than 80 years old
- Anejaculation
- Patient's will
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.
In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.
Read more
Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.
A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.
The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
Read the detailed description
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.
In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.
Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.
A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer.
According to results obtained, follow up will be tailored to patients (assessment for COVID 19 infections and/or further analysis/folliow-up in case of abnormal findings) The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.
The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
- Conditions
- SARS-CoV 2, Sexual Function and Fertility Disorders, Urinary Function Disorders, Urine, Semen
- Being tested
- SARS-CoV 2 RNA PCR Urine, SARS-CoV 2 RNA PCR Semen, Semen Qualitative Analysis, IIEF-5 questionnaire, Male Sexual Health Questionnaire (MSHQ)
- Keywords
- SARS-CoV 2, Sexual Function, Fertility, Urine, Semen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV 2 RNA PCR UrineDiagnostic test
Search for SARS-CoV 2 RNA in urine through PCR
SARS-CoV 2 RNA PCR SemenDiagnostic test
Search for SARS-CoV 2 RNA in Semen through PCR
Semen Qualitative AnalysisDiagnostic test
Search for Semen Alterations in patients with past SARS-CoV 2 infection
IIEF-5 questionnaireDiagnostic test
IIEF-5 assessment in patients with past SARS-CoV 2 infection
Male Sexual Health Questionnaire (MSHQ)Diagnostic test
Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection
IPSS questionnaireDiagnostic test
IPSS assessment in patients with past SARS-CoV 2 infection
SECRET questionnaireDiagnostic test
SECRET questionnaire assessment in patients with past SARS-CoV 2 infection
Interleukin assessment in semenDiagnostic test
Assessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV 2 Patients | Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections Receives: Diagnostic Test: SARS-CoV 2 RNA PCR Urine; Diagnostic Test: SARS-CoV 2 RNA PCR Semen; Diagnostic Test: Semen Qualitative Analysis; Diagnostic Test: IIEF-5 questionnaire; Diagnostic Test: Male Sexual Health Questionnaire (MSHQ); Diagnostic Test: IPSS questionnaire; Diagnostic Test: SECRET questionnaire; Diagnostic Test: Interleukin assessment in semen |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV 2 presence in semen
SARS-CoV 2 RNA PCR in semen
Measured: Enrollment
SARS-CoV 2 presence in urine
SARS-CoV 2 RNA PCR in urine
Measured: Enrollment
Inflammation in Semen
Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present
Measured: Enrollment
Semen quantitative and qualitative analysis
Spermiogram done following WHO guidelines and criteria
Measured: Enrollment
Secondary outcomes (4)
Erectile Function
International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
Measured: Enrollment
Sexual Habits
SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
Measured: Enrollment
Urinary function
International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
Measured: Enrollment
Sexual and Ejaculatory Function
Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start27 Jun 2020
- Primary completion1 Sep 2020
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Mauro Gacci, MD, Principal investigator, Careggi University HospitalSergio Serni, Prof, Study director, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446169
- Sponsor's protocol ID
- 17104_oss/2020
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2020
- Last updated
- 11 Oct 2021
- Results posted
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function
- ClinicalTrials.gov ID
- NCT04446169
- Acronym / sponsor ID
- 17104_oss/2020
- Conditions
- SARS-CoV 2, Sexual Function and Fertility Disorders, Urinary Function Disorders, Urine, Semen
- Keywords
- SARS-CoV 2, Sexual Function, Fertility, Urine, Semen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 24 Jun 2020 (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.
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.
In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.
Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.
A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.
The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
Detailed description
This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.
In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.
Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.
A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer.
According to results obtained, follow up will be tailored to patients (assessment for COVID 19 infections and/or further analysis/folliow-up in case of abnormal findings) The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.
The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV 2 Patients | – | Diagnostic Test: SARS-CoV 2 RNA PCR Urine, Diagnostic Test: SARS-CoV 2 RNA PCR Semen, Diagnostic Test: Semen Qualitative Analysis, Diagnostic Test: IIEF-5 questionnaire, Diagnostic Test: Male Sexual Health Questionnaire (MSHQ), Diagnostic Test: IPSS questionnaire, Diagnostic Test: SECRET questionnaire, Diagnostic Test: Interleukin assessment in semenPatients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort study on male patients with a documented previous infection for SARS-CoV2, including symptomatic and asymptomatic patients.Patients need to be eligible for the inclusion criteria and to sign the informed consent to be enrolled to the study
Key inclusion criteria (5 listed)
- Male Sex
- Age>18 years
- Will to participate to the study
- Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA)
- Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)
Key exclusion criteria (3 listed)
- Age more than 80 years old
- Anejaculation
- Patient's will
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 |
|---|---|---|
| SARS-CoV 2 RNA PCR UrineSearch for SARS-CoV 2 RNA in urine through PCR | Diagnostic test | SARS-CoV 2 Patients |
| SARS-CoV 2 RNA PCR SemenSearch for SARS-CoV 2 RNA in Semen through PCR | Diagnostic test | SARS-CoV 2 Patients |
| Semen Qualitative AnalysisSearch for Semen Alterations in patients with past SARS-CoV 2 infection | Diagnostic test | SARS-CoV 2 Patients |
| IIEF-5 questionnaireIIEF-5 assessment in patients with past SARS-CoV 2 infection | Diagnostic test | SARS-CoV 2 Patients |
| Male Sexual Health Questionnaire (MSHQ)Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection | Diagnostic test | SARS-CoV 2 Patients |
| IPSS questionnaireIPSS assessment in patients with past SARS-CoV 2 infection | Diagnostic test | SARS-CoV 2 Patients |
| SECRET questionnaireSECRET questionnaire assessment in patients with past SARS-CoV 2 infection | Diagnostic test | SARS-CoV 2 Patients |
| Interleukin assessment in semenAssessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present | Diagnostic test | SARS-CoV 2 Patients |
Primary outcome
SARS-CoV 2 presence in semen
Time frame: Enrollment
SARS-CoV 2 RNA PCR in semen
SARS-CoV 2 presence in urine
Time frame: Enrollment
SARS-CoV 2 RNA PCR in urine
Inflammation in Semen
Time frame: Enrollment
Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present
Semen quantitative and qualitative analysis
Time frame: Enrollment
Spermiogram done following WHO guidelines and criteria
4 secondary outcomes
Erectile Function
Time frame: Enrollment
Sexual Habits
Time frame: Enrollment
Urinary function
Time frame: Enrollment
Sexual and Ejaculatory Function
Time frame: Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Mauro Gacci, MD principal investigator
Careggi University Hospital
Sergio Serni, Prof study director
University of Florence
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 SARS-CoV 2 and Sexual Function and Fertility Disorders, run by University of Florence 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 11 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV 2 presence in semen (time frame: Enrollment). The study lists 4 primary outcomes in all. 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 11 Oct 2021.