Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2020-07-05
2021-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study Drug
Study drug
Pulmozyme
Pulmozyme 2.5 mg BID
Placebo
Placebo
Placebo
Saline 2.5 mL BID
Interventions
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Pulmozyme
Pulmozyme 2.5 mg BID
Placebo
Saline 2.5 mL BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
South Shore Hospital
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Benjamiin Raby
Chief of Respiratory Diseases
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Benjamin Raby, MD
Role: primary
Robert Fowler
Role: backup
Rebecca Baron, MD
Role: primary
Katherin Alejandra Zamrano Vera
Role: backup
Stephanie Smith, PhD
Role: primary
Other Identifiers
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P00035140
Identifier Type: -
Identifier Source: org_study_id