<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446169</url>
  </required_header>
  <id_info>
    <org_study_id>17104_oss/2020</org_study_id>
    <nct_id>NCT04446169</nct_id>
  </id_info>
  <brief_title>COVID-19 (SARS-CoV-2) in Urine and Semen</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliero-Universitaria Careggi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florence</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is part of the current global emergency scenario due to infection with&#xD;
      Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to&#xD;
      investigate the possibility of the presence of the virus within the seminal fluid and in the&#xD;
      urine of infected patients, both during the acute phase and remotely. Current evidences show&#xD;
      that Coronaviruses can be present inside the testicle and sperm in other species, such as in&#xD;
      feline and avian models.&#xD;
&#xD;
      In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in&#xD;
      urine, as several studies with a large sample found no traces of the same with Real-Time&#xD;
      Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid&#xD;
      amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain&#xD;
      Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from&#xD;
      the last negative nasopharyngeal swab.&#xD;
&#xD;
      Given the topicality of the problem, our study has the objective of specifically researching&#xD;
      the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.&#xD;
&#xD;
      A saliva sample will also be collected as a control. At the moment there are no studies in&#xD;
      literature that tested this possibility. If confirmed, it would lead to find out another&#xD;
      potential method of transmission, the sexual one, in asymptomatic patients or apparently no&#xD;
      longer infectious with negative buffer. The rationale for our study is the evidence that in&#xD;
      other species this type of transmission by coronaviruses is possible and that at present it&#xD;
      has not been verified in mankind.&#xD;
&#xD;
      The relevance of the study would be both in the case of a negative result, as the first study&#xD;
      in its generally, both in the case of a positive result, due to the possibility of&#xD;
      introducing new prevention measures in the long run.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is part of the current global emergency scenario due to infection with&#xD;
      Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to&#xD;
      investigate the possibility of the presence of the virus within the seminal fluid and in the&#xD;
      urine of infected patients, both during the acute phase and remotely. Current evidences show&#xD;
      that Coronaviruses can be present inside the testicle and sperm in other species, such as in&#xD;
      feline and avian models.&#xD;
&#xD;
      In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in&#xD;
      urine, as several studies with a large sample found no traces of the same with Real-Time&#xD;
      Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid&#xD;
      amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain&#xD;
      Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from&#xD;
      the last negative nasopharyngeal swab.&#xD;
&#xD;
      Given the topicality of the problem, our study has the objective of specifically researching&#xD;
      the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.&#xD;
&#xD;
      A saliva sample will also be collected as a control. At the moment there are no studies in&#xD;
      literature that tested this possibility. If confirmed, it would lead to find out another&#xD;
      potential method of transmission, the sexual one, in asymptomatic patients or apparently no&#xD;
      longer infectious with negative buffer.&#xD;
&#xD;
      According to results obtained, follow up will be tailored to patients (assessment for COVID&#xD;
      19 infections and/or further analysis/folliow-up in case of abnormal findings) The rationale&#xD;
      for our study is the evidence that in other species this type of transmission by&#xD;
      coronaviruses is possible and that at present it has not been verified in mankind.&#xD;
&#xD;
      The relevance of the study would be both in the case of a negative result, as the first study&#xD;
      in its generally, both in the case of a positive result, due to the possibility of&#xD;
      introducing new prevention measures in the long run.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2020</start_date>
  <completion_date type="Actual">September 2, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV 2 presence in semen</measure>
    <time_frame>Enrollment</time_frame>
    <description>SARS-CoV 2 RNA PCR in semen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV 2 presence in urine</measure>
    <time_frame>Enrollment</time_frame>
    <description>SARS-CoV 2 RNA PCR in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammation in Semen</measure>
    <time_frame>Enrollment</time_frame>
    <description>Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Semen quantitative and qualitative analysis</measure>
    <time_frame>Enrollment</time_frame>
    <description>Spermiogram done following WHO guidelines and criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erectile Function</measure>
    <time_frame>Enrollment</time_frame>
    <description>International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Habits</measure>
    <time_frame>Enrollment</time_frame>
    <description>SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary function</measure>
    <time_frame>Enrollment</time_frame>
    <description>International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual and Ejaculatory Function</measure>
    <time_frame>Enrollment</time_frame>
    <description>Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>Sexual Function and Fertility Disorders</condition>
  <condition>Urinary Function Disorders</condition>
  <condition>Urine</condition>
  <condition>Semen</condition>
  <arm_group>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
    <description>Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV 2 RNA PCR Urine</intervention_name>
    <description>Search for SARS-CoV 2 RNA in urine through PCR</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV 2 RNA PCR Semen</intervention_name>
    <description>Search for SARS-CoV 2 RNA in Semen through PCR</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Semen Qualitative Analysis</intervention_name>
    <description>Search for Semen Alterations in patients with past SARS-CoV 2 infection</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IIEF-5 questionnaire</intervention_name>
    <description>IIEF-5 assessment in patients with past SARS-CoV 2 infection</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Male Sexual Health Questionnaire (MSHQ)</intervention_name>
    <description>Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IPSS questionnaire</intervention_name>
    <description>IPSS assessment in patients with past SARS-CoV 2 infection</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SECRET questionnaire</intervention_name>
    <description>SECRET questionnaire assessment in patients with past SARS-CoV 2 infection</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Interleukin assessment in semen</intervention_name>
    <description>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</description>
    <arm_group_label>SARS-CoV 2 Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective cohort study on male patients with a documented previous infection for&#xD;
        SARS-CoV2, including symptomatic and asymptomatic patients.Patients need to be eligible for&#xD;
        the inclusion criteria and to sign the informed consent to be enrolled to the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male Sex&#xD;
&#xD;
          -  Age&gt;18 years&#xD;
&#xD;
          -  Will to participate to the study&#xD;
&#xD;
          -  Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2&#xD;
             RNA)&#xD;
&#xD;
          -  Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for&#xD;
             SARS-CoV2 RNA, done following WHO guidelines)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age more than 80 years old&#xD;
&#xD;
          -  Anejaculation&#xD;
&#xD;
          -  Patient's will&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Semen analysis</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mauro Gacci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Careggi University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergio Serni, Prof</last_name>
    <role>Study Director</role>
    <affiliation>University of Florence</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AOU Careggi</name>
      <address>
        <city>Florence</city>
        <state>Tuscany</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Florence</investigator_affiliation>
    <investigator_full_name>Simone Morselli</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV 2</keyword>
  <keyword>Sexual Function</keyword>
  <keyword>Fertility</keyword>
  <keyword>Urine</keyword>
  <keyword>Semen</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446169
org study id: 17104_oss/2020
nct id: NCT04446169
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: SARS-CoV 2 presence in semen
time frame: Enrollment
description: SARS-CoV 2 RNA PCR in semen
measure: SARS-CoV 2 presence in urine
time frame: Enrollment
description: SARS-CoV 2 RNA PCR in urine
measure: Inflammation in Semen
time frame: Enrollment
description: Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present
measure: Semen quantitative and qualitative analysis
time frame: Enrollment
description: Spermiogram done following WHO guidelines and criteria
measure: Erectile Function
time frame: Enrollment
description: International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
measure: Sexual Habits
time frame: Enrollment
description: SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
measure: Urinary function
time frame: Enrollment
description: International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
measure: Sexual and Ejaculatory Function
time frame: Enrollment
description: Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function
arm group label: SARS-CoV 2 Patients
description: Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections
intervention type: Diagnostic Test
intervention name: SARS-CoV 2 RNA PCR Urine
description: Search for SARS-CoV 2 RNA in urine through PCR
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: SARS-CoV 2 RNA PCR Semen
description: Search for SARS-CoV 2 RNA in Semen through PCR
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: Semen Qualitative Analysis
description: Search for Semen Alterations in patients with past SARS-CoV 2 infection
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: IIEF-5 questionnaire
description: IIEF-5 assessment in patients with past SARS-CoV 2 infection
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: Male Sexual Health Questionnaire (MSHQ)
description: Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: IPSS questionnaire
description: IPSS assessment in patients with past SARS-CoV 2 infection
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: SECRET questionnaire
description: SECRET questionnaire assessment in patients with past SARS-CoV 2 infection
arm group label: SARS-CoV 2 Patients
intervention type: Diagnostic Test
intervention name: Interleukin assessment in semen
description: 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
arm group label: SARS-CoV 2 Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Semen analysis
minimum age: 18 Years
maximum age: 80 Years
last name: Mauro Gacci, MD
role: Principal Investigator
affiliation: Careggi University Hospital
last name: Sergio Serni, Prof
role: Study Director
affiliation: University of Florence
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Florence
investigator full name: Simone Morselli
investigator title: MD
sharing ipd: No