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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04446169
Recruitment Status : Active, not recruiting
First Posted : June 24, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Azienda Ospedaliero-Universitaria Careggi
Information provided by (Responsible Party):
Simone Morselli, 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.


Condition or disease Intervention/treatment
SARS-CoV 2 Sexual Function and Fertility Disorders Urinary Function Disorders Urine Semen Diagnostic Test: SARS-CoV 2 RNA PCR Urine Diagnostic Test: SARS-CoV 2 RNA PCR Semen Diagnostic Test: Semen Qualitative Analysis Diagnostic Test: IIEF-5 questionnaire Diagnostic Test: Male Sexual Health Questionnaire (MSHQ) Diagnostic Test: IPSS questionnaire Diagnostic Test: SECRET questionnaire Diagnostic Test: Interleukin assessment in semen

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.

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 27, 2020
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SARS-CoV 2 Patients
Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Semen analysis
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446169


Locations
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Italy
AOU Careggi
Florence, Tuscany, Italy, 50134
Sponsors and Collaborators
University of Florence
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Principal Investigator: Mauro Gacci, MD Careggi University Hospital
Study Director: Sergio Serni, Prof University of Florence
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Responsible Party: Simone Morselli, MD, University of Florence
ClinicalTrials.gov Identifier: NCT04446169    
Other Study ID Numbers: 17104_oss/2020
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simone Morselli, University of Florence:
SARS-CoV 2
Sexual Function
Fertility
Urine
Semen
Additional relevant MeSH terms:
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Disease
Pathologic Processes