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Completed

NCT Number: NCT04446169

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

AOU Careggi

Florence, Tuscany, 50134, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV 2 RNA PCR Urine

Diagnostic Test

Search for SARS-CoV 2 RNA in urine through PCR

SARS-CoV 2 RNA PCR Semen

Diagnostic Test

Search for SARS-CoV 2 RNA in Semen through PCR

Semen Qualitative Analysis

Diagnostic Test

Search for Semen Alterations in patients with past SARS-CoV 2 infection

IIEF-5 questionnaire

Diagnostic Test

IIEF-5 assessment in patients with past SARS-CoV 2 infection

Male Sexual Health Questionnaire (MSHQ)

Diagnostic Test

Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection

IPSS questionnaire

Diagnostic Test

IPSS assessment in patients with past SARS-CoV 2 infection

SECRET questionnaire

Diagnostic Test

SECRET questionnaire assessment in patients with past SARS-CoV 2 infection

Interleukin assessment in semen

Diagnostic Test

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

Primary outcomes

  1. SARS-CoV 2 presence in semen

    Time frame: Enrollment

    SARS-CoV 2 RNA PCR in semen

  2. SARS-CoV 2 presence in urine

    Time frame: Enrollment

    SARS-CoV 2 RNA PCR in urine

  3. Inflammation in Semen

    Time frame: Enrollment

    Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present

  4. Semen quantitative and qualitative analysis

    Time frame: Enrollment

    Spermiogram done following WHO guidelines and criteria

Secondary outcomes

  1. Erectile Function

    Time frame: Enrollment

    International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function

  2. Sexual Habits

    Time frame: Enrollment

    SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals

  3. Urinary function

    Time frame: Enrollment

    International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function

  4. Sexual and Ejaculatory Function

    Time frame: Enrollment

    Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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