NCT04402944

Pulmozyme to Improve COVID-19 ARDS Outcomes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID

Interventions

Type	Name	Description
DRUG	Pulmozyme	Pulmozyme 2.5 mg BID
DRUG	Placebo	Saline 2.5 mL BID

Timeline

• Start date: 2020-07-05
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-05-27
• Last updated: 2021-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study