Status:
UNKNOWN
Pulmozyme to Improve COVID-19 ARDS Outcomes
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
South Shore Hospital
Conditions:
COVID
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief 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. Pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04402944
Start Date
July 5 2020
End Date
December 31 2021
Last Update
December 17 2021
Active Locations (3)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
South Shore Hospital
Weymouth, Massachusetts, United States, 02190