COVID-19 (SARS-CoV-2) in Urine and Semen
- Conditions
- Sexual Function and Fertility DisordersUrineUrinary Function DisordersSARS-CoV 2Semen
- Interventions
- Diagnostic Test: SARS-CoV 2 RNA PCR UrineDiagnostic Test: SARS-CoV 2 RNA PCR SemenDiagnostic Test: Semen Qualitative AnalysisDiagnostic Test: IIEF-5 questionnaireDiagnostic Test: Male Sexual Health Questionnaire (MSHQ)Diagnostic Test: IPSS questionnaireDiagnostic Test: SECRET questionnaireDiagnostic Test: Interleukin assessment in semen
- Registration Number
- NCT04446169
- Lead Sponsor
- University of Florence
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 43
- 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)
- Age more than 80 years old
- Anejaculation
- Patient's will
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV 2 Patients SECRET questionnaire Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients Interleukin assessment in semen Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients SARS-CoV 2 RNA PCR Semen Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients IPSS questionnaire Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients Semen Qualitative Analysis Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients SARS-CoV 2 RNA PCR Urine Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients IIEF-5 questionnaire Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections SARS-CoV 2 Patients Male Sexual Health Questionnaire (MSHQ) Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections
- Primary Outcome Measures
Name Time Method SARS-CoV 2 presence in semen Enrollment SARS-CoV 2 RNA PCR in semen
Semen quantitative and qualitative analysis Enrollment Spermiogram done following WHO guidelines and criteria
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
- Secondary Outcome Measures
Name Time Method Sexual Habits Enrollment SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
Sexual and Ejaculatory Function Enrollment Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function
Urinary function Enrollment International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
Erectile Function Enrollment International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
Trial Locations
- Locations (1)
AOU Careggi
🇮🇹Florence, Tuscany, Italy