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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.
 
ClinicalTrials.gov Identifier: NCT04402944
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : June 12, 2020
Sponsor:
Collaborator:
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
Estimated Study Start Date : June 18, 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
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 ]
    oxygenation

  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 ]
    mortality



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • ICU admission for pneumonia complicated by respiratory failure.
  • RT-PCR (or equivalent) confirmed COVID-19 infection.
  • Intubated and on mechanical ventilation within 48 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
  • Patients unable to provide informed consent or who do not have a healthcare proxy to provide consent
  • Patients are eligible for enrollment if they are already enrolled in another interventional study that does not involved inhaled medications
  • Pregnant or breastfeeding
  • Use of extracorporeal membrane oxygenation (ECMO)
  • Prisoner status

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 ClinicalTrials.gov identifier (NCT number): NCT04402944


Contacts
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Contact: Robert Fowler 6173551834 robert.fowler@childrens.harvard.edu

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
ClinicalTrials.gov Identifier: NCT04402944    
Other Study ID Numbers: P00035140
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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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:
Pulmozyme
Pneumonia
ARDS