COVID-19 (SARS-CoV-2) in Urine and Semen
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SARS-CoV 2 Patients Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections |
Diagnostic Test: SARS-CoV 2 RNA PCR Urine
Search for SARS-CoV 2 RNA in urine through PCR
Diagnostic Test: SARS-CoV 2 RNA PCR Semen
Search for SARS-CoV 2 RNA in Semen through PCR
Diagnostic Test: Semen Qualitative Analysis
Search for Semen Alterations in patients with past SARS-CoV 2 infection
Diagnostic Test: IIEF-5 questionnaire
IIEF-5 assessment in patients with past SARS-CoV 2 infection
Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)
Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection
Diagnostic Test: IPSS questionnaire
IPSS assessment in patients with past SARS-CoV 2 infection
Diagnostic Test: SECRET questionnaire
SECRET questionnaire assessment in patients with past SARS-CoV 2 infection
Diagnostic Test: Interleukin assessment in semen
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
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Outcome Measures
Primary Outcome Measures
- SARS-CoV 2 presence in semen [Enrollment]
SARS-CoV 2 RNA PCR in semen
- SARS-CoV 2 presence in urine [Enrollment]
SARS-CoV 2 RNA PCR in urine
- Inflammation in Semen [Enrollment]
Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present
- Semen quantitative and qualitative analysis [Enrollment]
Spermiogram done following WHO guidelines and criteria
Secondary Outcome Measures
- Erectile Function [Enrollment]
International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
- Sexual Habits [Enrollment]
SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
- Urinary function [Enrollment]
International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
- Sexual and Ejaculatory Function [Enrollment]
Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male Sex
-
Age>18 years
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Will to participate to the study
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Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA)
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Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)
Exclusion Criteria:
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Age more than 80 years old
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Anejaculation
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Patient's will
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AOU Careggi | Florence | Tuscany | Italy | 50134 |
Sponsors and Collaborators
- University of Florence
- Azienda Ospedaliero-Universitaria Careggi
Investigators
- Principal Investigator: Mauro Gacci, MD, Careggi University Hospital
- Study Director: Sergio Serni, Prof, University of Florence
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17104_oss/2020