<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/NCT04416061</url>
  </required_header>
  <id_info>
    <org_study_id>RC-2020-08</org_study_id>
    <nct_id>NCT04416061</nct_id>
  </id_info>
  <brief_title>The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic</brief_title>
  <acronym>COVID-19</acronym>
  <official_title>The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic: A Descriptive Study of Patients With SARS-CoV-2 RT-PCR Performed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Sanatorium &amp; Hospital</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hong Kong Sanatorium &amp; Hospital</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>
      Hong Kong public healthcare system is facing tremendous pressure under the COVID-19 pandemic.&#xD;
      As the virus spread in Hong Kong, Hong Kong Sanatorium &amp; Hospital (HKSH) is one of the first&#xD;
      private hospitals which immediately provide reliable and rapid COVID-19 test -- Reverse&#xD;
      Transcription Polymerase Chain Reaction (RT-PCR). Early provision of the RT-PCR screening&#xD;
      test for COVID-19 not only facilitates identification of COVID-19 but also contains the&#xD;
      spread of the virus in the community and frontline medical staff.&#xD;
&#xD;
      Since description of role of private hospital in Hong Kong amid COVID-19 pandemic is lacking,&#xD;
      this study will describe COVID-19 screening algorithm and methodology. A retrospective&#xD;
      analysis on clinical characteristics, laboratory findings as well as outcome of patients who&#xD;
      underwent COVID-19 test in HKSH is also performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Proportion of asymptomatic subjects</measure>
    <time_frame>1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong</time_frame>
    <description>Proportion of asymptomatic subjects (%) who underwent COVID 19 test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with recent contact history</measure>
    <time_frame>1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong</time_frame>
    <description>Proportion of subjects (%) with recent contact history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with recent travel history</measure>
    <time_frame>1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong</time_frame>
    <description>Proportion of subjects (%) with recent travel history</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Subjects underwent COVID-19 test</arm_group_label>
    <description>Subjects who underwent COVID-19 test in HKSH during the study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID 19 Diagnostic Test</intervention_name>
    <description>COVID 19 Diagnostic Test</description>
    <arm_group_label>Subjects underwent COVID-19 test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who underwent COVID-19 test in HKSH during the study period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who underwent COVID-19 test in HKSH during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonpaul Sze Tsing Zee, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Sanatorium &amp; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Sanatorium &amp; Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Sanatorium &amp; Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Jonpaul ST Zee</investigator_full_name>
    <investigator_title>Specialist in Infectious Disease</investigator_title>
  </responsible_party>
  <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>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/NCT04416061
org study id: RC-2020-08
nct id: NCT04416061
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hong Kong public healthcare system is facing tremendous pressure under the COVID-19 pandemic.
      As the virus spread in Hong Kong, Hong Kong Sanatorium & Hospital (HKSH) is one of the first
      private hospitals which immediately provide reliable and rapid COVID-19 test -- Reverse
      Transcription Polymerase Chain Reaction (RT-PCR). Early provision of the RT-PCR screening
      test for COVID-19 not only facilitates identification of COVID-19 but also contains the
      spread of the virus in the community and frontline medical staff.

      Since description of role of private hospital in Hong Kong amid COVID-19 pandemic is lacking,
      this study will describe COVID-19 screening algorithm and methodology. A retrospective
      analysis on clinical characteristics, laboratory findings as well as outcome of patients who
      underwent COVID-19 test in HKSH is also performed.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of asymptomatic subjects
time frame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
description: Proportion of asymptomatic subjects (%) who underwent COVID 19 test
measure: Proportion of subjects with recent contact history
time frame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
description: Proportion of subjects (%) with recent contact history
measure: Proportion of subjects with recent travel history
time frame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
description: Proportion of subjects (%) with recent travel history
arm group label: Subjects underwent COVID-19 test
description: Subjects who underwent COVID-19 test in HKSH during the study period
intervention type: Diagnostic Test
intervention name: COVID 19 Diagnostic Test
description: COVID 19 Diagnostic Test
arm group label: Subjects underwent COVID-19 test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jonpaul Sze Tsing Zee, MBChB
role: Principal Investigator
affiliation: Hong Kong Sanatorium & Hospital
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Sanatorium & Hospital
investigator full name: Dr. Jonpaul ST Zee
investigator title: Specialist in Infectious Disease
mesh term: COVID-19
sharing ipd: No