Clincosm LogoSign in Get a demo

Pulmozyme to Improve COVID-19 ARDS Outcomes

Sponsor
Boston Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04402944
Collaborator
Brigham and Women's Hospital (Other), South Shore Hospital (Other)
60
Enrollment
3
Locations
2
Arms
17.9
Anticipated Duration (Months)
20
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Pulmozyme to Improve COVID-19 ARDS Outcomes
Actual Study Start Date :
Jul 5, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Drug

Study drug

Drug: Pulmozyme
Pulmozyme 2.5 mg BID
Other Names:
  • Dornase alfa

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Saline 2.5 mL BID

    Outcome Measures

    Primary Outcome Measures

    1. Ventilator-free days at 28 days [28 days]

      Primary outcome

    Secondary Outcome Measures

    1. change in airway resistance [28 days]

      change in airway resistance

    2. change in lung compliance [28 days]

      Change in lung compliance

    3. oxygenation (PaO2/FiO2 ratio) [28 days]

      oxygenation

    4. length of stay (ICU and hospital) [28 days]

      length of stay

    5. rate of barotrauma [28 days]

      rate of batotrauma

    6. mortality. [28 days]

      mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ICU admission for pneumonia complicated by respiratory failure.

    • RT-PCR (or equivalent) confirmed COVID-19 infection.

    • Intubated and on mechanical ventilation within 120 hours of initiation of mechanical ventilation.

    • Age ≥ 3 years of age.

    Exclusion Criteria:

    • Allergy or known intolerance to Pulmozyme or Chinese Hamster Ovary cell products

    • History of moderate to severe asthma, cystic fibrosis, or severe COPD (baseline FEV1 ≤ 40% predicted)

    • Active malignancy other than basal cell melanoma or in situ breast cancer

    • Unstable angina

    • Chronic liver disease as judged by the investigator that would pose significant risk to participation

    • Chronic renal disease as judged by the investigator that would pose significant risk to participation

    • Inability to obtain informed consent from patient or legally authorized representative (LAR)

    • Pregnant or breastfeeding Use of extracorporeal membrane oxygenation (ECMO)

    • Prisoner status

    • Concurrent treatment with other inhaled investigational agent for COVID-19**

    • Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)

    • Moribund patient not expected to survive 24 hours

    • Active hemoptysis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115
    2 Brigham and Women's Hospital Boston Massachusetts United States 02115
    3 South Shore Hospital Weymouth Massachusetts United States 02190

    Sponsors and Collaborators

    • Boston Children's Hospital
    • Brigham and Women's Hospital
    • South Shore Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamiin Raby, Chief of Respiratory Diseases, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04402944
    Other Study ID Numbers:
    • P00035140
    First Posted:
    May 27, 2020
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Benjamiin Raby, Chief of Respiratory Diseases, Boston Children's Hospital
    Pulmozyme
    Pneumonia
    ARDS

    Study Results

    No Results Posted as of Dec 17, 2021