Recruiting
Phase 2

Pulmozyme

Sponsor:

Boston Children's Hospital

Code:

NCT04402944

Conditions

COVID

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

Pulmozyme

Placebo

Study Details

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.

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

Study ID

NCT04402944

Start date

Jul 5, 2020

Status verified date

Dec, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Drug

Study drug

placebo comparator: Placebo

Placebo

Interventions

Pulmozyme

Pulmozyme 2.5 mg BID

Placebo

Saline 2.5 mL BID

Primary outcome measure

  • Ventilator-free days at 28 days [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Robert Fowler

6173551834robert.fowler@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Robert Fowler

6173551834robert.fowler@childrens.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Katherin Alejandra Zamrano Vera

617-525-7540mailto:kzambranovera@bwh.harvard.edu

South Shore Hospital

Recruiting

Weymouth, Massachusetts, United States, 02190

Contacts

Stephanie Smith, PhD

781-624-4369ssmith3@southshorehealth.org

Principal Investigator:

Dilip Nataraj, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 17, 2021

Last verified

Dec, 2021

Keywords

  • Pulmozyme
  • Pneumonia
  • ARDS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2021-12-17.