<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/NCT04480580</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-SURG</org_study_id>
    <nct_id>NCT04480580</nct_id>
  </id_info>
  <brief_title>Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery</brief_title>
  <official_title>Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cagliari</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cagliari</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>
      We have herein analysed the patients admitted to our Department that underwent serologic&#xD;
      tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the&#xD;
      setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to&#xD;
      evaluate if security measures are necessary for this context.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence of SARS-CoV-2</measure>
    <time_frame>3 months</time_frame>
    <description>Positivity of specific IgM or IgG</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Covid19</condition>
  <condition>Surgery</condition>
  <condition>SARS (Severe Acute Respiratory Syndrome)</condition>
  <arm_group>
    <arm_group_label>Hospitalized patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2 Ab</intervention_name>
    <description>Patient test for specific antibodies for SARS-CoV-2</description>
    <arm_group_label>Hospitalized patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in surgical department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized during pandemic spread&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>AOU Cagliari</name>
      <address>
        <city>Cagliari</city>
        <state>CA</state>
        <zip>09100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cagliari</investigator_affiliation>
    <investigator_full_name>Fabio Medas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV-2, surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <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/NCT04480580
org study id: COVID-SURG
nct id: NCT04480580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We have herein analysed the patients admitted to our Department that underwent serologic
      tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the
      setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to
      evaluate if security measures are necessary for this context.
observational model: Cohort
time perspective: Retrospective
measure: Seroprevalence of SARS-CoV-2
time frame: 3 months
description: Positivity of specific IgM or IgG
arm group label: Hospitalized patients
intervention type: Diagnostic Test
intervention name: SARS-CoV-2 Ab
description: Patient test for specific antibodies for SARS-CoV-2
arm group label: Hospitalized patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Cagliari
investigator full name: Fabio Medas
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: No