Pulmozyme to Improve COVID-19 ARDS Outcomes

NCT04402944 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: P00035140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Pulmozyme; Pneumonia; ARDS

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days at 28 days

  Primary outcome

  28 days

Secondary Outcomes (6)

• change in airway resistance

  28 days

• change in lung compliance

  28 days

• oxygenation (PaO2/FiO2 ratio)

  28 days

• length of stay (ICU and hospital)

  28 days

• rate of barotrauma

  28 days

Study Arms (2)

Study Drug

EXPERIMENTAL

Study drug

Drug: Pulmozyme

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pulmozyme DRUG

Pulmozyme 2.5 mg BID

Also known as: Dornase alfa

Study Drug

Placebo DRUG

Saline 2.5 mL BID

Placebo

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Brigham and Women's Hospital: collaborator
• South Shore Hospital: collaborator

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Robert Fowler

CONTACT

6173551834; robert.fowler@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Respiratory Diseases

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 27, 2020
• Study Start: July 5, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (3)