<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/NCT04436484</url>
  </required_header>
  <id_info>
    <org_study_id>20/HEP/381</org_study_id>
    <nct_id>NCT04436484</nct_id>
  </id_info>
  <brief_title>Immune Biomarkers of Outcome From COVID-19</brief_title>
  <acronym>IBOC</acronym>
  <official_title>Immune Dysfunction in COVID-19: Investigation of Mechanisms and Identification of Immune Biomarkers of Clinical Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Plymouth NHS Trust</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>
      A new virus to humans, first identified in December 2019, is causing a global pandemic with&#xD;
      over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to&#xD;
      coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Around 1 in&#xD;
      every 5 people with COVID-19 have more severe infection needing treatment in hospital. Up to&#xD;
      half of them require help with breathing in an intensive care unit. Information we have so&#xD;
      far about COVID-19 suggests that people with underlying conditions, such as high blood&#xD;
      pressure and heart disease, or older people are at higher risk of having severe illness.&#xD;
      Scientists do not yet understand why but think it may be related to the immune system.&#xD;
&#xD;
      SARS-CoV2 activates the immune system causing inflammation in the lungs, which is also seen&#xD;
      in circulating immune cells in the blood. Preliminary reports show that the response of the&#xD;
      immune system can be inappropriate, both overactive and also poorly responsive (exhausted).&#xD;
      Changes in the type and function of immune cells have been linked to increased risk of severe&#xD;
      disease or death from COVID-19.&#xD;
&#xD;
      In this study, the investigators will look for markers of immune function when a person first&#xD;
      attends hospital, which can be used to predict whether they will go on to have a more severe&#xD;
      infection. This will help treat patients more effectively, for example, by moving high risk&#xD;
      patients to an intensive care setting at an early stage. The team will investigate the immune&#xD;
      system in detail in 200 patients with COVID-19 attending University Hospitals Plymouth. The&#xD;
      investigators will look for changes in the number, type and function of circulating immune&#xD;
      cells and measure whether these changes are linked to severity of the infection or death. The&#xD;
      investigators will use established techniques to measure immune function that could be&#xD;
      rapidly put into routine hospital care to help guide treatment for individual patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2020</start_date>
  <completion_date type="Actual">June 14, 2021</completion_date>
  <primary_completion_date type="Actual">June 14, 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>Mortality</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 4 and Day 10</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease severity</measure>
    <time_frame>Day 4, 10 and 28</time_frame>
    <description>Sequential Organ Failure Assessment (SOFA) score (range 0-24; higher score predicts worse outcome)</description>
  </secondary_outcome>
  <enrollment type="Actual">42</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Peripheral blood sampling</intervention_name>
    <description>Non-interventional study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People with confirmed COVID-19 infection who are inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients attending UHP with COVID-19 infection&#xD;
&#xD;
          -  Participants capable of giving informed consent, or if not capable, assent from a&#xD;
             personal or nominated consultee&#xD;
&#xD;
          -  Age of 18 or over&#xD;
&#xD;
          -  Confirmed COVID-19 infection by PCR or antibody testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants on immune suppressing medications within preceding 4 weeks (including&#xD;
             systemic corticosteroids with average daily dose equivalent to prednisolone 20 mg)&#xD;
&#xD;
          -  Participants on treatment with systemic chemotherapy&#xD;
&#xD;
          -  Participants with known immunodeficiency states&#xD;
&#xD;
          -  Participants already administered immunomodulating or antiviral agents as part of an&#xD;
             interventional trial (this does not include non-specific therapies such as&#xD;
             hydroxycholoroquine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ashwin D Dhanda, MRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Plymouth NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Plymouth NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inflammation</keyword>
  <keyword>immune response</keyword>
  <keyword>biomarker</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>No</sharing_ipd>
    <ipd_description>Study findings will be reported but IPD is not planned to be shared.</ipd_description>
  </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/NCT04436484
org study id: 20/HEP/381
nct id: NCT04436484
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A new virus to humans, first identified in December 2019, is causing a global pandemic with
      over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to
      coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Around 1 in
      every 5 people with COVID-19 have more severe infection needing treatment in hospital. Up to
      half of them require help with breathing in an intensive care unit. Information we have so
      far about COVID-19 suggests that people with underlying conditions, such as high blood
      pressure and heart disease, or older people are at higher risk of having severe illness.
      Scientists do not yet understand why but think it may be related to the immune system.

      SARS-CoV2 activates the immune system causing inflammation in the lungs, which is also seen
      in circulating immune cells in the blood. Preliminary reports show that the response of the
      immune system can be inappropriate, both overactive and also poorly responsive (exhausted).
      Changes in the type and function of immune cells have been linked to increased risk of severe
      disease or death from COVID-19.

      In this study, the investigators will look for markers of immune function when a person first
      attends hospital, which can be used to predict whether they will go on to have a more severe
      infection. This will help treat patients more effectively, for example, by moving high risk
      patients to an intensive care setting at an early stage. The team will investigate the immune
      system in detail in 200 patients with COVID-19 attending University Hospitals Plymouth. The
      investigators will look for changes in the number, type and function of circulating immune
      cells and measure whether these changes are linked to severity of the infection or death. The
      investigators will use established techniques to measure immune function that could be
      rapidly put into routine hospital care to help guide treatment for individual patients.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: up to 28 days
description: Mortality
measure: Mortality
time frame: Day 4 and Day 10
description: Mortality
measure: Disease severity
time frame: Day 4, 10 and 28
description: Sequential Organ Failure Assessment (SOFA) score (range 0-24; higher score predicts worse outcome)
intervention type: Diagnostic Test
intervention name: Peripheral blood sampling
description: Non-interventional study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Ashwin D Dhanda, MRCP PhD
role: Principal Investigator
affiliation: University Hospitals Plymouth NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: Study findings will be reported but IPD is not planned to be shared.