<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/NCT04497402</url>
  </required_header>
  <id_info>
    <org_study_id>SAPIENZAGENDERCOVID</org_study_id>
    <nct_id>NCT04497402</nct_id>
  </id_info>
  <brief_title>Sex-Informed Data in the COVID-19 Pandemic.</brief_title>
  <acronym>G-COV</acronym>
  <official_title>Sex-Informed Data in the COVID-19 Pandemic.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</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>
      Sex and gender matter to health equity, especially in a pandemic. Sex (a biological&#xD;
      attribute) and gender (a social construct) may influence an individual's susceptibility,&#xD;
      vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and&#xD;
      MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response&#xD;
      display ample sexual dimorphism.&#xD;
&#xD;
      The primary aim of the study is to determine whether sex differences in biomarkers of&#xD;
      platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical&#xD;
      cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality&#xD;
      due to COVID-19) exist in patients affected by COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Sex differences in platelet and immune function and COVID19 severity</measure>
    <time_frame>3 months</time_frame>
    <description>Sex differences in biomarkers of platelet and immune function correlate with severity of disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbiome and COVID19 severity</measure>
    <time_frame>3 months</time_frame>
    <description>Differences in the gut microbiome correlate with severity of disease</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>female COVID19 patients</arm_group_label>
    <description>Females with COVID19 disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>male COVID19 patients</arm_group_label>
    <description>Males with COVID19 disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>female matched COVID19-free patients</arm_group_label>
    <description>Free from disease COVID19 Females matched.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>male matched COVID19-free patients</arm_group_label>
    <description>Free from disease COVID19 males matched.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma, blood cell pellets and faeces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with laboratory confirmed SARS-Cov-2 infection (positive for real-time&#xD;
        reverse-transcriptase polymerase-chain reaction assay for pharyngeal swab specimens) of any&#xD;
        severity (from asymptomatic to severe manifestations).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with laboratory confirmed SARS-Cov-2 infection of any severity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Younger than 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We will apply the gender framework as defined by the Canadian Institutes for Health Research (CIHR) which includes 4 gender domains: Gender Identity; Gender Roles; Gender Relations; and Institutionalized Gender (https://cihr-irsc.gc.ca/e/50836.html). Such factors include occupation, employment, marital status, number of children, and household responsibilities.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stefania Basili, MD</last_name>
    <phone>0649972018</phone>
    <email>stefania.basili@uniroma1.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sapienza University of Rome - Policlinico Umberto I Roma</name>
      <address>
        <city>Rome</city>
        <zip>00166</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefania Basili, MD</last_name>
      <phone>+390649972018</phone>
      <email>stefania.basili@uniroma1.it</email>
    </contact>
    <investigator>
      <last_name>Stefania Basili, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lucia Stefanini, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valeria Raparelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guido Antonelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefano Corradini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto Cangemi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claudio Mastroianni, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcella Visentini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Ciardi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>December 27, 2021</last_update_submitted>
  <last_update_submitted_qc>December 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Stefania Basili</investigator_full_name>
    <investigator_title>Full Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>sex</keyword>
  <keyword>gender</keyword>
  <keyword>thrombosis</keyword>
  <keyword>immunity</keyword>
  <keyword>gut microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04497402
org study id: SAPIENZAGENDERCOVID
nct id: NCT04497402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sex and gender matter to health equity, especially in a pandemic. Sex (a biological
      attribute) and gender (a social construct) may influence an individual's susceptibility,
      vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and
      MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response
      display ample sexual dimorphism.

      The primary aim of the study is to determine whether sex differences in biomarkers of
      platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical
      cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality
      due to COVID-19) exist in patients affected by COVID-19.
observational model: Cohort
time perspective: Prospective
measure: Sex differences in platelet and immune function and COVID19 severity
time frame: 3 months
description: Sex differences in biomarkers of platelet and immune function correlate with severity of disease
measure: Gut microbiome and COVID19 severity
time frame: 3 months
description: Differences in the gut microbiome correlate with severity of disease
arm group label: female COVID19 patients
description: Females with COVID19 disease
arm group label: male COVID19 patients
description: Males with COVID19 disease
arm group label: female matched COVID19-free patients
description: Free from disease COVID19 Females matched.
arm group label: male matched COVID19-free patients
description: Free from disease COVID19 males matched.
serum, plasma, blood cell pellets and faeces
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: We will apply the gender framework as defined by the Canadian Institutes for Health Research (CIHR) which includes 4 gender domains: Gender Identity; Gender Roles; Gender Relations; and Institutionalized Gender (https://cihr-irsc.gc.ca/e/50836.html). Such factors include occupation, employment, marital status, number of children, and household responsibilities.
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefania Basili, MD
phone: 0649972018
email: stefania.basili@uniroma1.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Stefania Basili
investigator title: Full Professor of Internal Medicine
mesh term: COVID-19
sharing ipd: Undecided