This is a randomized double-blind placebo-controlled Phase II trial of recombinant humandeoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients withCOVID-19 pneumonia.Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanicalventilation will be invited to participate in this study. Potential subjects will beidentified from medical record review or from direct contact with physicians.Investigators will check medical history and confirm eligibility. Informed consent willbe obtained from either the patient or designated healthcare proxy.60 subjects will be enrolled. After obtaining informed consent, patients will berandomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longerreceiving mechanical ventilation, whichever is sooner plus standard of care vs. placebonormal saline 2.5 ml plus standard of care.
Drug: Pulmozyme
Pulmozyme 2.5 mg BID
Other Name: Dornase alfa
Drug: Placebo
Saline 2.5 mL BID
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
Boston Children's Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
Robert Fowler
6173551834
robert.fowler@childrens.harvard.edu