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Purpose

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

Eligibility

Eligible Ages
Over 3 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Benjamin Raby, MD

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Rebecca Baron, MD

South Shore Hospital
Weymouth, Massachusetts 02190
Contact:
Stephanie Smith, PhD
781-624-4369
ssmith3@southshorehealth.org

More Details

NCT ID
NCT04402944
Status
Unknown status
Sponsor
Boston Children's Hospital

Study Contact

Robert Fowler
6173551834
robert.fowler@childrens.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.