Clinical trial NCT04446169: COVID-19 (SARS-CoV-2) in Urine and Semen
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Sexual Function and Fertility Disorders
Urinary Function Disorders
Urine
Semen
Keywords: SARS-CoV 2
Sexual Function
Fertility
Urine
Semen
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2020-06-24
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Age more than 80 years old
* Anejaculation
* Patient's will

Primary outcomes:
measure: SARS-CoV 2 presence in semen
timeFrame: Enrollment
measure: SARS-CoV 2 presence in urine
timeFrame: Enrollment
measure: Inflammation in Semen
timeFrame: Enrollment
measure: Semen quantitative and qualitative analysis
timeFrame: Enrollment
Secondary outcomes:
measure: Erectile Function
timeFrame: Enrollment
measure: Sexual Habits
timeFrame: Enrollment
measure: Urinary function
timeFrame: Enrollment
measure: Sexual and Ejaculatory Function
timeFrame: Enrollment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi
state: Tuscany
Study officials:
affiliation: Careggi University Hospital
name: Mauro Gacci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Sergio Serni, Prof
role: STUDY_DIRECTOR
References: