<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/NCT04422691</url>
  </required_header>
  <id_info>
    <org_study_id>REK129805</org_study_id>
    <nct_id>NCT04422691</nct_id>
  </id_info>
  <brief_title>Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection</brief_title>
  <acronym>COVIDUS-NOR</acronym>
  <official_title>Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ullevaal University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nordlandssykehuset HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Drammen sykehus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</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>
      In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize&#xD;
      clinical tools for assessing and risk stratifying patients with suspected coronary infection&#xD;
      in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including&#xD;
      COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection&#xD;
      of lung pathology compatible with increasing severity of the COVID-19 disease. At the same&#xD;
      time, the use of ultrasound diagnostics in the emergency department could improve logistics&#xD;
      and reduce potential exposure of the corona virus to other health personnel.&#xD;
&#xD;
      The purpose of the study is to assess whether ultrasound findings correlates with physical&#xD;
      examination, labs, and other imaging diagnostics in patients with suspected or diagnosed&#xD;
      COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk&#xD;
      stratification. The project is conducted as a prospective multicenter study where ultrasound&#xD;
      diagnostics will be performed on patients with suspected coronary infection in the emergency&#xD;
      departments. Data collection takes place as part of the daily clinical evaluation of acute&#xD;
      patients in the emergency departments. The project is planned to be completed towards the end&#xD;
      of 2025.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of Covid-19 patients&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 30 days</time_frame>
    <description>30-day mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level-of-care</measure>
    <time_frame>up to 7 days</time_frame>
    <description>In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital length of stay</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen usage in the emergency department</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department length of stay</measure>
    <time_frame>Within 24 hours</time_frame>
    <description>in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotics usage</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical correlation</measure>
    <time_frame>Within 3 days</time_frame>
    <description>Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>COVID-19</condition>
  <condition>Pneumonia, Viral</condition>
  <condition>Pulmonary Infection</condition>
  <arm_group>
    <arm_group_label>Covid-19 suspected</arm_group_label>
    <description>Emergency department patients with suspected or diagnosed COVID-19 disease. All patients will be screened at triage and put into isolation if suspected disease. Ultrasound of the patients lungs will be performed after patient consent and findings will be recorded and categorized (Soldati et al., 2020). The use of ultrasound and registration of data will not affect the regular patient evaluation, treatment or logistics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung ultrasound</intervention_name>
    <description>After verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020.</description>
    <arm_group_label>Covid-19 suspected</arm_group_label>
    <other_name>Ultrasonography of the lungs</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pasients referred to the ED with signs and symptoms suspected of COVID-19 (including cough,&#xD;
        dyspnea, fever), patient already diagnosed with COVID-19, and patients with risk of being&#xD;
        in contact with corona virus will be eligible for study enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All emergency department patients with suspected or diagnosed COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative screening for COVID-19&#xD;
&#xD;
          -  recent negative COVID-19 test&#xD;
&#xD;
          -  no indication for isolation in the Emergency Department&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Petter Bjørnsen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTNU/St. Olav's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland universitetssykehus</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordland Hospital</name>
      <address>
        <city>Bodø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drammen sykehus</name>
      <address>
        <city>Drammen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sørlandet sykehus, Kristiansand</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ullevål University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Telemark HF</name>
      <address>
        <city>Skien</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger Universitetssjukehus</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <keyword>Norway</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Emergency Physicians</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia, Viral</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/NCT04422691
org study id: REK129805
nct id: NCT04422691
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize
      clinical tools for assessing and risk stratifying patients with suspected coronary infection
      in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including
      COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection
      of lung pathology compatible with increasing severity of the COVID-19 disease. At the same
      time, the use of ultrasound diagnostics in the emergency department could improve logistics
      and reduce potential exposure of the corona virus to other health personnel.

      The purpose of the study is to assess whether ultrasound findings correlates with physical
      examination, labs, and other imaging diagnostics in patients with suspected or diagnosed
      COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk
      stratification. The project is conducted as a prospective multicenter study where ultrasound
      diagnostics will be performed on patients with suspected coronary infection in the emergency
      departments. Data collection takes place as part of the daily clinical evaluation of acute
      patients in the emergency departments. The project is planned to be completed towards the end
      of 2025.
observational model: Cohort
time perspective: Cross-Sectional
measure: Mortality
time frame: up to 30 days
description: 30-day mortality
measure: Level-of-care
time frame: up to 7 days
description: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
measure: In-hospital length of stay
time frame: Up to 30 days
description: in days
measure: Oxygen usage in the emergency department
time frame: Within 24 hours
measure: Emergency department length of stay
time frame: Within 24 hours
description: in hours
measure: Antibiotics usage
time frame: Within 24 hours
measure: Clinical correlation
time frame: Within 3 days
description: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.
arm group label: Covid-19 suspected
description: Emergency department patients with suspected or diagnosed COVID-19 disease. All patients will be screened at triage and put into isolation if suspected disease. Ultrasound of the patients lungs will be performed after patient consent and findings will be recorded and categorized (Soldati et al., 2020). The use of ultrasound and registration of data will not affect the regular patient evaluation, treatment or logistics.
intervention type: Diagnostic Test
intervention name: Lung ultrasound
description: After verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020.
arm group label: Covid-19 suspected
other name: Ultrasonography of the lungs
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Petter Bjørnsen, MD, PhD
role: Principal Investigator
affiliation: NTNU/St. Olav's Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Pneumonia, Viral
sharing ipd: No