<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/NCT04460534</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01206-33</org_study_id>
    <nct_id>NCT04460534</nct_id>
  </id_info>
  <brief_title>Detection of COVID-19 (SARS-CoV-2) in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)</brief_title>
  <acronym>COVISPERM</acronym>
  <official_title>Detection of SARS-CoV-2 in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to look for the presence of SARS-CoV-2 in the semen of&#xD;
      patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective monocentric, open-label, prospective study of male patients with&#xD;
      CoV-2-SARS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Actual">May 12, 2021</completion_date>
  <primary_completion_date type="Actual">May 12, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Testing for the presence of COVID-19 (SARS-CoV-2 virus) in the semen</measure>
    <time_frame>48 hours</time_frame>
    <description>The search for the SARS-CoV-2 virus in semen will be carried out by RT-PCR analysis with the RealStar kit developed by Altona Diagnostics. The extraction of the nucleic acid suitable for sperm uses the Pure MagNA technique (Diagnostics ROCHE). This is an extraction technique that has already been validated for HIV-type RNA viruses in semen.&#xD;
The biological samples will be analysed either during the study or bio-banked and analysed at the end of the study. Only semen samples from patients detected positive for SARS-CoV-2 by RT-PCR on nasopharyngeal swab will be analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinetics of SARS-CoV-2 virus presence in the semen</measure>
    <time_frame>1 month</time_frame>
    <description>Patients who have been found to carry the SARS-CoV-2 virus in their semen will be recalled after one month to re-test for the virus. In case of a positive re-test, a new search will be scheduled and so on until a negative result is found.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>COHORT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>diagnostic</intervention_name>
    <description>The principle of this study is to propose to patients in whom a COVID-19 infection is suspected and who are screened for the disease, the joint search for the virus in the semen.</description>
    <arm_group_label>COHORT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patient between the ages of 18 and 65 who has read and signed the consent form&#xD;
             for participation in the study.&#xD;
&#xD;
          -  Outpatient or inpatient without signs of respiratory severity, likely to be mobile&#xD;
&#xD;
          -  Patient whose medical condition warrants screening for COVID-19 by nasopharyngeal swab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under protective custody, guardianship or trusteeship&#xD;
&#xD;
          -  Patient not affiliated to the French social security system&#xD;
&#xD;
          -  Inability to provide the subject with informed information and/or written informed&#xD;
             consent: dementia, psychosis, consciousness disorders, non-French speaking patient&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Semen collection</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucie DELAROCHE, Pharm D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital privé de Parly II</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Privé de Parly II</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04460534
org study id: 2020-A01206-33
nct id: NCT04460534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to look for the presence of SARS-CoV-2 in the semen of
      patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.
This is a prospective monocentric, open-label, prospective study of male patients with
      CoV-2-SARS.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Testing for the presence of COVID-19 (SARS-CoV-2 virus) in the semen
time frame: 48 hours
description: The search for the SARS-CoV-2 virus in semen will be carried out by RT-PCR analysis with the RealStar kit developed by Altona Diagnostics. The extraction of the nucleic acid suitable for sperm uses the Pure MagNA technique (Diagnostics ROCHE). This is an extraction technique that has already been validated for HIV-type RNA viruses in semen.
The biological samples will be analysed either during the study or bio-banked and analysed at the end of the study. Only semen samples from patients detected positive for SARS-CoV-2 by RT-PCR on nasopharyngeal swab will be analyzed.
measure: Kinetics of SARS-CoV-2 virus presence in the semen
time frame: 1 month
description: Patients who have been found to carry the SARS-CoV-2 virus in their semen will be recalled after one month to re-test for the virus. In case of a positive re-test, a new search will be scheduled and so on until a negative result is found.
arm group label: COHORT
arm group type: Experimental
description: Cohort
intervention type: Diagnostic Test
intervention name: diagnostic
description: The principle of this study is to propose to patients in whom a COVID-19 infection is suspected and who are screened for the disease, the joint search for the virus in the semen.
arm group label: COHORT
criteria: 
gender: Male
gender based: Yes
gender description: Semen collection
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lucie DELAROCHE, Pharm D
role: Principal Investigator
affiliation: Hôpital privé de Parly II
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No