Pulmozyme to Improve COVID-19 ARDS Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Pulmozyme to Improve COVID-19 ARDS Outcomes

Conditions
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COVID

Intervention / Treatment
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* Drug: Pulmozyme
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug<br>Study drug | Drug: Pulmozyme<br>* Pulmozyme 2.5 mg BID<br>* Other names: Dornase alfa;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Saline 2.5 mL BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days at 28 days | Primary outcome | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in airway resistance | change in airway resistance | 28 days | 
| change in lung compliance | Change in lung compliance | 28 days | 
| oxygenation (PaO2/FiO2 ratio) | oxygenation | 28 days | 
| length of stay (ICU and hospital) | length of stay | 28 days | 
| rate of barotrauma | rate of batotrauma | 28 days | 
| mortality. | mortality | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, Pulmozyme, Pneumonia