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Pulmozyme to Improve COVID-19 ARDS Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04402944
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : April 9, 2021
Brigham and Women's Hospital
Information provided by (Responsible Party):
Benjamiin Raby, Boston Children's Hospital

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
COVID Drug: Pulmozyme Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 5, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study Drug
Study drug
Drug: Pulmozyme
Pulmozyme 2.5 mg BID
Other Name: Dornase alfa

Placebo Comparator: Placebo
Drug: Placebo
Saline 2.5 mL BID

Primary Outcome Measures :
  1. Ventilator-free days at 28 days [ Time Frame: 28 days ]
    Primary outcome

Secondary Outcome Measures :
  1. change in airway resistance [ Time Frame: 28 days ]
    change in airway resistance

  2. change in lung compliance [ Time Frame: 28 days ]
    Change in lung compliance

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

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

  5. rate of barotrauma [ Time Frame: 28 days ]
    rate of batotrauma

  6. mortality. [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04402944

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Contact: Robert Fowler 6173551834

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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Benjamin Raby, MD         
Contact: Robert Fowler    6173551834   
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rebecca Baron, MD         
Contact: Katherin Alejandra Zamrano Vera    617-525-7540   
Sponsors and Collaborators
Boston Children's Hospital
Brigham and Women's Hospital
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Responsible Party: Benjamiin Raby, Chief of Respiratory Diseases, Boston Children's Hospital Identifier: NCT04402944    
Other Study ID Numbers: P00035140
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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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, Boston Children's Hospital: