<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/NCT04414657</url>
  </required_header>
  <id_info>
    <org_study_id>CTC HFV2</org_study_id>
    <nct_id>NCT04414657</nct_id>
  </id_info>
  <brief_title>USZ BioResource COVID-19</brief_title>
  <official_title>Development of a SARS-CoV-2 Research Biobank and Databank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regina Grossmann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Mono-centric. Blood sampling for biobank development, including linkage to patient data&#xD;
      (resource for research on COVID19).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    sufficient patient number reached; flattening out of pandemic in Switzerland&#xD;
  </why_stopped>
  <start_date type="Actual">April 9, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>blood sampling for biobank</measure>
    <time_frame>2 years</time_frame>
    <description>development of a biobank</description>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>COVID19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampling for biobank</intervention_name>
    <description>blood sampling for biobank</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      PBMCs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        SARS-CoV-2 infektion (according to WHO guideline)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  m/f age &gt; 18 years&#xD;
&#xD;
          -  SARS-CoV-2 infektion (according to WHO guideline)&#xD;
&#xD;
          -  hospitalisation, general ward&#xD;
&#xD;
          -  acceptable language knowledge&#xD;
&#xD;
          -  voluntary IFC and biobank appendix&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra indication for blood sampling&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Regina Grossmann, Dr med</last_name>
    <role>Study Director</role>
    <affiliation>Head of Clinical Trials Center University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Clinical Trials Center</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 2, 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>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Regina Grossmann</investigator_full_name>
    <investigator_title>Dr. med.</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/NCT04414657
org study id: CTC HFV2
nct id: NCT04414657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mono-centric. Blood sampling for biobank development, including linkage to patient data
      (resource for research on COVID19).
observational model: Cohort
time perspective: Prospective
measure: blood sampling for biobank
time frame: 2 years
description: development of a biobank
intervention type: Other
intervention name: blood sampling for biobank
description: blood sampling for biobank
PBMCs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Regina Grossmann, Dr med
role: Study Director
affiliation: Head of Clinical Trials Center University Hospital Zurich
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Regina Grossmann
investigator title: Dr. med.
mesh term: COVID-19
sharing ipd: No