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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Pulmozyme 2.5 mg BID
Saline 2.5 mL BID
Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGSouth Shore Hospital
Weymouth, Massachusetts, United States
RECRUITINGVentilator-free days at 28 days
Primary outcome
Time frame: 28 days
change in airway resistance
change in airway resistance
Time frame: 28 days
change in lung compliance
Change in lung compliance
Time frame: 28 days
oxygenation (PaO2/FiO2 ratio)
oxygenation
Time frame: 28 days
length of stay (ICU and hospital)
length of stay
Time frame: 28 days
rate of barotrauma
rate of batotrauma
Time frame: 28 days
mortality.
mortality
Time frame: 28 days
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