<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/NCT04484545</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 282807</org_study_id>
    <nct_id>NCT04484545</nct_id>
  </id_info>
  <brief_title>Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection</brief_title>
  <official_title>Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glasgow Royal Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glasgow Royal Infirmary</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>
      As of 27th May 2020, approximately 5.7 million people worldwide are known to have been&#xD;
      infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this&#xD;
      viral disease for an individual is associated with a widespread perturbation of immune,&#xD;
      physiological and metabolic parameters (2, 3). These whole body changes could be considered&#xD;
      characteristic of a systemic inflammatory response to tissue injury and it has been long&#xD;
      recognised that a large and ongoing systemic inflammatory response is associated with the&#xD;
      development of multiple organ failure and infective disease (4, 5).&#xD;
&#xD;
      One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory&#xD;
      response (2). This response bears striking similarity to the systemic inflammatory response&#xD;
      experienced by patients undergoing major elective surgical resections for cancer (6, 7).&#xD;
      Indeed, the systemic inflammatory response and the associated metabolic stress has been most&#xD;
      well characterised in major elective surgery, where the relationship between the magnitude of&#xD;
      the post-operative systemic inflammatory response and the development of post-operative&#xD;
      complications is now well recognised, as is the effect of patient comorbidity on this&#xD;
      relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally&#xD;
      invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and&#xD;
      enhanced recovery protocols.&#xD;
&#xD;
      The aim of the present study was to examine whether routinely collected clinicopathological&#xD;
      characteristics of patients with COVID-19 on admission were informative on the immune and&#xD;
      metabolic stress experienced by patients with COVID-19 and whether such characteristics were&#xD;
      informative on subsequent outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electronic patient records for patients who attended the Emergency Department (ED) and Acute&#xD;
      Assessment Unit (AAU) at Glasgow Royal Infirmary (GRI), Glasgow, U.K., during the initial&#xD;
      7-week period of the COVID-19 pandemic in Glasgow city (17th March 2020 - 1st May 2020) were&#xD;
      examined for routine clinical, laboratory and clinical outcome data. GRI is a university&#xD;
      teaching hospital that serves an urban population with a high burden of socio-economic&#xD;
      deprivation and offers the full spectrum of adult acute receiving specialties to patients&#xD;
      over 16 years old. In line with NHS policy, this study was approved by the NHS Greater&#xD;
      Glasgow and Clyde Caldicott guardian.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>30-day</time_frame>
    <description>30-day mortality and prognostic score</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Alive or Dead with COVID-19 diagnosis</arm_group_label>
    <description>Patients selected in phase 1 of study according to Health Protection Scotland criteria for diagnosis of COVID-19 infection Patients selected for phase 2 (validation phase) by PCR result</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Prognostic score</intervention_name>
    <description>Validation of scores of systemic inflammatory response</description>
    <arm_group_label>Alive or Dead with COVID-19 diagnosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        General hospital population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical, radiological and PCR positive COVID-19 diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donogh Maguire, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS GGC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glasgow Royal Infirmary</name>
      <address>
        <city>Glasgow</city>
        <zip>G4 0SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glasgow Royal Infirmary</investigator_affiliation>
    <investigator_full_name>Dr. Donogh Maguire</investigator_full_name>
    <investigator_title>Emergency Medicine Consultant</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>Yes</sharing_ipd>
    <ipd_description>Anonymised patient data will be made available on reasonable request</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
  </patient_data>
  <pending_results>
    <submitted>May 10, 2021</submitted>
    <returned>May 17, 2021</returned>
  </pending_results>
  <!-- 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/NCT04484545
org study id: IRAS 282807
nct id: NCT04484545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As of 27th May 2020, approximately 5.7 million people worldwide are known to have been
      infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this
      viral disease for an individual is associated with a widespread perturbation of immune,
      physiological and metabolic parameters (2, 3). These whole body changes could be considered
      characteristic of a systemic inflammatory response to tissue injury and it has been long
      recognised that a large and ongoing systemic inflammatory response is associated with the
      development of multiple organ failure and infective disease (4, 5).

      One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory
      response (2). This response bears striking similarity to the systemic inflammatory response
      experienced by patients undergoing major elective surgical resections for cancer (6, 7).
      Indeed, the systemic inflammatory response and the associated metabolic stress has been most
      well characterised in major elective surgery, where the relationship between the magnitude of
      the post-operative systemic inflammatory response and the development of post-operative
      complications is now well recognised, as is the effect of patient comorbidity on this
      relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally
      invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and
      enhanced recovery protocols.

      The aim of the present study was to examine whether routinely collected clinicopathological
      characteristics of patients with COVID-19 on admission were informative on the immune and
      metabolic stress experienced by patients with COVID-19 and whether such characteristics were
      informative on subsequent outcome.
Electronic patient records for patients who attended the Emergency Department (ED) and Acute
      Assessment Unit (AAU) at Glasgow Royal Infirmary (GRI), Glasgow, U.K., during the initial
      7-week period of the COVID-19 pandemic in Glasgow city (17th March 2020 - 1st May 2020) were
      examined for routine clinical, laboratory and clinical outcome data. GRI is a university
      teaching hospital that serves an urban population with a high burden of socio-economic
      deprivation and offers the full spectrum of adult acute receiving specialties to patients
      over 16 years old. In line with NHS policy, this study was approved by the NHS Greater
      Glasgow and Clyde Caldicott guardian.
observational model: Cohort
time perspective: Retrospective
measure: mortality
time frame: 30-day
description: 30-day mortality and prognostic score
arm group label: Alive or Dead with COVID-19 diagnosis
description: Patients selected in phase 1 of study according to Health Protection Scotland criteria for diagnosis of COVID-19 infection Patients selected for phase 2 (validation phase) by PCR result
intervention type: Diagnostic Test
intervention name: Prognostic score
description: Validation of scores of systemic inflammatory response
arm group label: Alive or Dead with COVID-19 diagnosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Donogh Maguire, PhD
role: Principal Investigator
affiliation: NHS GGC
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Glasgow Royal Infirmary
investigator full name: Dr. Donogh Maguire
investigator title: Emergency Medicine Consultant
mesh term: COVID-19
sharing ipd: Yes
ipd description: Anonymised patient data will be made available on reasonable request
ipd info type: Clinical Study Report (CSR)
ipd time frame: 6 months
submitted: May 10, 2021
returned: May 17, 2021