<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/NCT04402944</url>
  </required_header>
  <id_info>
    <org_study_id>P00035140</org_study_id>
    <nct_id>NCT04402944</nct_id>
  </id_info>
  <brief_title>Pulmozyme to Improve COVID-19 ARDS Outcomes</brief_title>
  <official_title>Pulmozyme to Improve COVID-19 ARDS Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Shore Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized double-blind placebo-controlled Phase II trial of recombinant human&#xD;
      deoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients with&#xD;
      COVID-19 pneumonia.&#xD;
&#xD;
      Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanical&#xD;
      ventilation will be invited to participate in this study. Potential subjects will be&#xD;
      identified from medical record review or from direct contact with physicians. Investigators&#xD;
      will check medical history and confirm eligibility. Informed consent will be obtained from&#xD;
      either the patient or designated healthcare proxy.&#xD;
&#xD;
      60 subjects will be enrolled. After obtaining informed consent, patients will be randomized&#xD;
      2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longer receiving&#xD;
      mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline&#xD;
      2.5 ml plus standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilator-free days at 28 days</measure>
    <time_frame>28 days</time_frame>
    <description>Primary outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in airway resistance</measure>
    <time_frame>28 days</time_frame>
    <description>change in airway resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in lung compliance</measure>
    <time_frame>28 days</time_frame>
    <description>Change in lung compliance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygenation (PaO2/FiO2 ratio)</measure>
    <time_frame>28 days</time_frame>
    <description>oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay (ICU and hospital)</measure>
    <time_frame>28 days</time_frame>
    <description>length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of barotrauma</measure>
    <time_frame>28 days</time_frame>
    <description>rate of batotrauma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality.</measure>
    <time_frame>28 days</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Study Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pulmozyme</intervention_name>
    <description>Pulmozyme 2.5 mg BID</description>
    <arm_group_label>Study Drug</arm_group_label>
    <other_name>Dornase alfa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline 2.5 mL BID</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU admission for pneumonia complicated by respiratory failure.&#xD;
&#xD;
          -  RT-PCR (or equivalent) confirmed COVID-19 infection.&#xD;
&#xD;
          -  Intubated and on mechanical ventilation within 120 hours of initiation of mechanical&#xD;
             ventilation.&#xD;
&#xD;
          -  Age ≥ 3 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or known intolerance to Pulmozyme or Chinese Hamster Ovary cell products&#xD;
&#xD;
          -  History of moderate to severe asthma, cystic fibrosis, or severe COPD (baseline FEV1 ≤&#xD;
             40% predicted)&#xD;
&#xD;
          -  Active malignancy other than basal cell melanoma or in situ breast cancer&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Chronic liver disease as judged by the investigator that would pose significant risk&#xD;
             to participation&#xD;
&#xD;
          -  Chronic renal disease as judged by the investigator that would pose significant risk&#xD;
             to participation&#xD;
&#xD;
          -  Inability to obtain informed consent from patient or legally authorized representative&#xD;
             (LAR)&#xD;
&#xD;
          -  Pregnant or breastfeeding Use of extracorporeal membrane oxygenation (ECMO)&#xD;
&#xD;
          -  Prisoner status&#xD;
&#xD;
          -  Concurrent treatment with other inhaled investigational agent for COVID-19**&#xD;
&#xD;
          -  Patient, surrogate, or physician not committed to full support (exception: a patient&#xD;
             will not be excluded if he/she would receive all supportive care except for attempts&#xD;
             at resuscitation from cardiac arrest)&#xD;
&#xD;
          -  Moribund patient not expected to survive 24 hours&#xD;
&#xD;
          -  Active hemoptysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Robert Fowler</last_name>
    <phone>6173551834</phone>
    <email>robert.fowler@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Raby, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Robert Fowler</last_name>
      <phone>6173551834</phone>
      <email>robert.fowler@childrens.harvard.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Baron, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Katherin Alejandra Zamrano Vera</last_name>
      <phone>617-525-7540</phone>
      <email>mailto:kzambranovera@bwh.harvard.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Smith, PhD</last_name>
      <phone>781-624-4369</phone>
      <email>ssmith3@southshorehealth.org</email>
    </contact>
    <investigator>
      <last_name>Dilip Nataraj, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Benjamiin Raby</investigator_full_name>
    <investigator_title>Chief of Respiratory Diseases</investigator_title>
  </responsible_party>
  <keyword>Pulmozyme</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>ARDS</keyword>
  <!-- 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/NCT04402944
org study id: P00035140
nct id: NCT04402944
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a randomized double-blind placebo-controlled Phase II trial of recombinant human
      deoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients with
      COVID-19 pneumonia.

      Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanical
      ventilation will be invited to participate in this study. Potential subjects will be
      identified from medical record review or from direct contact with physicians. Investigators
      will check medical history and confirm eligibility. Informed consent will be obtained from
      either the patient or designated healthcare proxy.

      60 subjects will be enrolled. After obtaining informed consent, patients will be randomized
      2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longer receiving
      mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline
      2.5 ml plus standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ventilator-free days at 28 days
time frame: 28 days
description: Primary outcome
measure: change in airway resistance
time frame: 28 days
description: change in airway resistance
measure: change in lung compliance
time frame: 28 days
description: Change in lung compliance
measure: oxygenation (PaO2/FiO2 ratio)
time frame: 28 days
description: oxygenation
measure: length of stay (ICU and hospital)
time frame: 28 days
description: length of stay
measure: rate of barotrauma
time frame: 28 days
description: rate of batotrauma
measure: mortality.
time frame: 28 days
description: mortality
arm group label: Study Drug
arm group type: Experimental
description: Study drug
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Pulmozyme
description: Pulmozyme 2.5 mg BID
arm group label: Study Drug
other name: Dornase alfa
intervention type: Drug
intervention name: Placebo
description: Saline 2.5 mL BID
arm group label: Placebo
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Fowler
phone: 6173551834
email: robert.fowler@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Benjamiin Raby
investigator title: Chief of Respiratory Diseases