NCT04446169

COVID-19 (SARS-CoV-2) in Urine and Semen

COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: University of Florence · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• SARS-CoV 2
• Sexual Function and Fertility Disorders
• Urinary Function Disorders
• Urine
• Semen

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-27
• Primary completion: 2020-09-01
• Completion: 2021-09-02
• First posted: 2020-06-24
• Last updated: 2021-10-11

Locations

1 site across 1 country: Italy