Pulmozyme to Improve COVID-19 ARDS Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: COVID
• Intervention / Treatment: Drug: Pulmozyme; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robert Fowler; Phone Number: 6173551834; Email: robert.fowler@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Robert Fowler; Phone Number: 6173551834; Email: robert.fowler@childrens.harvard.edu
      • Contact: Benjamin Raby, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Rebecca Baron, MD
      • Contact: Katherin Alejandra Zamrano Vera; Phone Number: 617-525-7540; Email: mailto:kzambranovera@bwh.harvard.edu
    • Weymouth, Massachusetts, United States, 02190
      • Recruiting
      • South Shore Hospital
      • Contact: Stephanie Smith, PhD; Phone Number: 781-624-4369; Email: ssmith3@southshorehealth.org
      • Principal Investigator: Dilip Nataraj, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Saline 2.5 mL BID
EXPERIMENTAL: Study Drug; Study drug	Drug: Pulmozyme; Pulmozyme 2.5 mg BID; Other Names: Dornase alfa

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Brigham and Women's Hospital; South Shore Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Pneumonia; ARDS; Pulmozyme
• Other Study ID Numbers: P00035140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes