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

U

University of Florence (UNIFI)

Status

Completed

Conditions

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

Treatments

Diagnostic Test: Semen Qualitative Analysis
Diagnostic Test: SECRET questionnaire
Diagnostic Test: SARS-CoV 2 RNA PCR Urine
Diagnostic Test: IPSS questionnaire
Diagnostic Test: Interleukin assessment in semen
Diagnostic Test: IIEF-5 questionnaire
Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)
Diagnostic Test: SARS-CoV 2 RNA PCR Semen

Study type

Observational

Funder types

Other

Identifiers

NCT04446169
17104_oss/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

SARS-CoV 2 Patients
Description:
Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections
Treatment:
Diagnostic Test: Semen Qualitative Analysis
Diagnostic Test: SARS-CoV 2 RNA PCR Semen
Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)
Diagnostic Test: SECRET questionnaire
Diagnostic Test: IPSS questionnaire
Diagnostic Test: SARS-CoV 2 RNA PCR Urine
Diagnostic Test: IIEF-5 questionnaire
Diagnostic Test: Interleukin assessment in semen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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