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.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital