<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/NCT04474236</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0182</org_study_id>
    <secondary_id>2020-A01445-34</secondary_id>
    <nct_id>NCT04474236</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound for COVID-19 Initial Triage and Monitoring</brief_title>
  <acronym>QUICK</acronym>
  <official_title>Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung&#xD;
      ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initial triage assessment is the cornerstone of first-line medical management for COVID-19&#xD;
      patients. Only an accurate and fast evaluation of COVID-19 patients respiratory system&#xD;
      integrity, can allow optimal treatment care and medical resources attribution. Despite its&#xD;
      very large deployment, the use of thoracic Computed Tomography (CT scan) for COVID-19&#xD;
      patients severity assessment is currently debated. Actually CT-scan use in this setting: i)&#xD;
      it is associated with risky in/out hospital patient's transport, both in terms of medical&#xD;
      management of patient's critical conditions and risk of COVID-19 nosocomial transmission, ii)&#xD;
      risks related to x-ray exposure iii) CT-scan is a snapshot of respiratory system integrity&#xD;
      and does not provide data that might be used for patient's monitoring. LUS is a non-invasive,&#xD;
      non-ionizing, fully bedside imaging tool. Investigators team has previously contributed to&#xD;
      the development and validation of LUS for critically ill patient's management. To the extent&#xD;
      of our knowledge, there is neither data regarding COVID-19 patient's LUS patterns, nor about&#xD;
      the potential link between LUS data, patient's severity and outcome.&#xD;
&#xD;
      The investigators hypothesize that the combined use of LUS and clinical data (Q-SOFA score,&#xD;
      SpiO2/FiO2) recorded at COVID-19 patients hospital admission, will allow to accurately&#xD;
      predict short-term outcome. The investigators expect to predict at patient's hospital&#xD;
      admission, the patient's clinical status at 24h: favorable (spontaneous ventilation with O2 &lt;&#xD;
      6 l/min) or unfavorable (spontaneous ventilation with O2 &gt; 6 l/min or under mechanical&#xD;
      ventilation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">March 7, 2021</completion_date>
  <primary_completion_date type="Actual">March 7, 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>Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data</measure>
    <time_frame>Day 1</time_frame>
    <description>Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on LUS (12 thoracic regions) and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data</measure>
    <time_frame>Day 1</time_frame>
    <description>Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>Day 28</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>COVID-19</condition>
  <condition>Acute Respiratory Failure</condition>
  <condition>Triage</condition>
  <condition>Lung Ultrasound</condition>
  <condition>CT Scan</condition>
  <arm_group>
    <arm_group_label>COVID-19 patients</arm_group_label>
    <description>Adult (&gt; 18 years) with Proven COVID-19 (specific PCR from respiratory track sample)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>thoracic lung ultrasound</intervention_name>
    <description>Patients will be recruited the day of their hospital admission. All patients will be assessed by thoracic Computed Tomography scan then immediately before/after CT scan, patients will be clinically assessed (Q-SOFA, SpiO2/FiO2) and a lung ultrasound evaluation (mean time of evaluation 7 min +/- 3 min; fully respect of COVID-19 barrier measures) will be performed by an investigator. Patients clinical status and outcomes will be extracted from patient's medical file at day 1 and day 28 from patient's admission by investigators blinded from previously recorded lung ultrasound data.</description>
    <arm_group_label>COVID-19 patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pilot study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult (&gt; 18 years).&#xD;
&#xD;
          -  Proven COVID-19 (specific PCR from respiratory track sample)&#xD;
&#xD;
          -  CT scan prescribed by physician in charge, independently of research.&#xD;
&#xD;
          -  Patients consent (or surrogate decision maker's consent in case of need).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Reduction or cessation of active treatment.&#xD;
&#xD;
          -  Patient under guardianship, tutelage measure or judicial protection&#xD;
&#xD;
          -  Patient deprived of liberty by judicial order&#xD;
&#xD;
          -  No French health insurance.&#xD;
&#xD;
          -  Pregnancy or nursing woman.&#xD;
&#xD;
          -  Enrolled in another trial evaluating thoracic imaging.&#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>Benjamine SARTON, ph</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Acute Respiratory Failure</keyword>
  <keyword>Triage</keyword>
  <keyword>Lung Ultrasound</keyword>
  <keyword>CT scan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04474236
org study id: RC31/20/0182
secondary id: 2020-A01445-34
nct id: NCT04474236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung
      ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.
Initial triage assessment is the cornerstone of first-line medical management for COVID-19
      patients. Only an accurate and fast evaluation of COVID-19 patients respiratory system
      integrity, can allow optimal treatment care and medical resources attribution. Despite its
      very large deployment, the use of thoracic Computed Tomography (CT scan) for COVID-19
      patients severity assessment is currently debated. Actually CT-scan use in this setting: i)
      it is associated with risky in/out hospital patient's transport, both in terms of medical
      management of patient's critical conditions and risk of COVID-19 nosocomial transmission, ii)
      risks related to x-ray exposure iii) CT-scan is a snapshot of respiratory system integrity
      and does not provide data that might be used for patient's monitoring. LUS is a non-invasive,
      non-ionizing, fully bedside imaging tool. Investigators team has previously contributed to
      the development and validation of LUS for critically ill patient's management. To the extent
      of our knowledge, there is neither data regarding COVID-19 patient's LUS patterns, nor about
      the potential link between LUS data, patient's severity and outcome.

      The investigators hypothesize that the combined use of LUS and clinical data (Q-SOFA score,
      SpiO2/FiO2) recorded at COVID-19 patients hospital admission, will allow to accurately
      predict short-term outcome. The investigators expect to predict at patient's hospital
      admission, the patient's clinical status at 24h: favorable (spontaneous ventilation with O2 <
      6 l/min) or unfavorable (spontaneous ventilation with O2 > 6 l/min or under mechanical
      ventilation).
observational model: Cohort
time perspective: Prospective
measure: Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data
time frame: Day 1
description: Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on LUS (12 thoracic regions) and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.
measure: Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data
time frame: Day 1
description: Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.
measure: mortality
time frame: Day 28
description: mortality
arm group label: COVID-19 patients
description: Adult (> 18 years) with Proven COVID-19 (specific PCR from respiratory track sample)
intervention type: Other
intervention name: thoracic lung ultrasound
description: Patients will be recruited the day of their hospital admission. All patients will be assessed by thoracic Computed Tomography scan then immediately before/after CT scan, patients will be clinically assessed (Q-SOFA, SpiO2/FiO2) and a lung ultrasound evaluation (mean time of evaluation 7 min +/- 3 min; fully respect of COVID-19 barrier measures) will be performed by an investigator. Patients clinical status and outcomes will be extracted from patient's medical file at day 1 and day 28 from patient's admission by investigators blinded from previously recorded lung ultrasound data.
arm group label: COVID-19 patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamine SARTON, ph
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Insufficiency
sharing ipd: Undecided