<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/NCT04477668</url>
  </required_header>
  <id_info>
    <org_study_id>RC20/306/R</org_study_id>
    <nct_id>NCT04477668</nct_id>
  </id_info>
  <brief_title>Helmet Non-Invasive Ventilation for COVID-19 Patients</brief_title>
  <acronym>Helmet-COVID</acronym>
  <official_title>Helmet Non-Invasive Ventilation for COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Abdulaziz Medical City, Riyadh, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Fahd Hospital of the University, Al Khobar, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aseer Central Hospital, Abha, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Faisal Specialist Hospital &amp; Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Fahad Hospital, Madinah, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Al Amiri Hospital, Kuwait</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Abdulaziz University Hospital, Jeddah, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Saud Medical City, Riyadh, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Abdullah International Medical Research Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce&#xD;
      28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia&#xD;
      and acute hypoxemic respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a pragmatic parallel randomized control trial that will compare helmet&#xD;
      nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The&#xD;
      trial will be implemented in multiple centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2021</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">November 16, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>28-day all-cause mortality</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>all cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intubation rate within 28 days</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>endotracheal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>180 days from randomization</time_frame>
    <description>ICU death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality (censored at day 180)</measure>
    <time_frame>180 days from randomization</time_frame>
    <description>hospital death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>180 days from randomization</time_frame>
    <description>length of stay in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU free days at day 28</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>days not in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive ventilation-free days at day 28</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>days without ventilator support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal replacement therapy-free days at day 28</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>days without renal replacement therapy received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressor-free days at day 28</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>days without vasopressor support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome: skin pressure ulcers</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>presence of pressure ulcers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome: barotrauma</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>incidence of barotrauma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events (including cardiovascular events and device complications)</measure>
    <time_frame>28 days from randomization</time_frame>
    <description>reporting of abovementioned adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>180-day all-cause mortality</measure>
    <time_frame>180 days from randomization</time_frame>
    <description>all cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up study: 180-day 5-level EQ-5D version</measure>
    <time_frame>180 days from randomization</time_frame>
    <description>The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">322</enrollment>
  <condition>COVID-19</condition>
  <condition>Acute Hypoxemic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Helmet group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be allocated to helmet non-invasive ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be allocated to standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Helmet non-invasive ventilation</intervention_name>
    <description>Patients will be allocated to helmet non-invasive ventilation</description>
    <arm_group_label>Helmet group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed COVID-19&#xD;
&#xD;
          -  Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult&#xD;
             patients will adhere to their local standard (16 or 18 years)&#xD;
&#xD;
          -  Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio &lt;200 despite supplemental&#xD;
             oxygen with a partial or non-rebreathing mask at a flow rate &gt;10 L/min or above&#xD;
&#xD;
          -  Intact airway protective gag reflex&#xD;
&#xD;
          -  Able to follow instructions (e.g. squeeze hand on command, eye contact with care&#xD;
             provider, stick out tongue on command, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior intubation during this hospital admission&#xD;
&#xD;
          -  Cardiopulmonary arrest&#xD;
&#xD;
          -  Glasgow coma scale &lt;12&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Upper airway obstruction&#xD;
&#xD;
          -  Active epistaxis&#xD;
&#xD;
          -  Requirement for more than one vasopressor to maintain mean arterial pressure &gt; 65 mm&#xD;
             Hg&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Imminent intubation&#xD;
&#xD;
          -  Patients with do not intubate orders or equivalent&#xD;
&#xD;
          -  Enrolled in another trial for which co-enrolment is not approved including trials on&#xD;
             mechanical ventilation&#xD;
&#xD;
          -  Patients already treated with helmet&#xD;
&#xD;
          -  Patients with chronic carbon dioxide retention (PaCO2 &gt;45)&#xD;
&#xD;
          -  Previous enrolment in this trial&#xD;
&#xD;
          -  The primary cause of respiratory failure is not heart failure as judged by the&#xD;
             treating team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaseen Arabi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdulaziz Medical City - Riyadh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs</name>
      <address>
        <city>Riyadh</city>
        <zip>11426</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>helmet nonivasive ventilation</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/NCT04477668
org study id: RC20/306/R
nct id: NCT04477668
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce
      28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia
      and acute hypoxemic respiratory failure
This will be a pragmatic parallel randomized control trial that will compare helmet
      nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The
      trial will be implemented in multiple centers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 28-day all-cause mortality
time frame: 28 days from randomization
description: all cause mortality
measure: Intubation rate within 28 days
time frame: 28 days from randomization
description: endotracheal intubation
measure: ICU mortality
time frame: 180 days from randomization
description: ICU death
measure: Hospital mortality (censored at day 180)
time frame: 180 days from randomization
description: hospital death
measure: Hospital length of stay
time frame: 180 days from randomization
description: length of stay in the hospital
measure: ICU free days at day 28
time frame: 28 days from randomization
description: days not in ICU
measure: Invasive ventilation-free days at day 28
time frame: 28 days from randomization
description: days without ventilator support
measure: Renal replacement therapy-free days at day 28
time frame: 28 days from randomization
description: days without renal replacement therapy received
measure: Vasopressor-free days at day 28
time frame: 28 days from randomization
description: days without vasopressor support
measure: Safety outcome: skin pressure ulcers
time frame: 28 days from randomization
description: presence of pressure ulcers
measure: Safety outcome: barotrauma
time frame: 28 days from randomization
description: incidence of barotrauma
measure: Serious adverse events (including cardiovascular events and device complications)
time frame: 28 days from randomization
description: reporting of abovementioned adverse events
measure: 180-day all-cause mortality
time frame: 180 days from randomization
description: all cause mortality
measure: Follow-up study: 180-day 5-level EQ-5D version
time frame: 180 days from randomization
description: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
arm group label: Helmet group
arm group type: Experimental
description: Patients will be allocated to helmet non-invasive ventilation
arm group label: Control group
arm group type: No Intervention
description: Patients will be allocated to standard of care
intervention type: Device
intervention name: Helmet non-invasive ventilation
description: Patients will be allocated to helmet non-invasive ventilation
arm group label: Helmet group
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Yaseen Arabi, MD
role: Principal Investigator
affiliation: King Abdulaziz Medical City - Riyadh
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Insufficiency
sharing ipd: Undecided