Pulmozyme to Improve COVID-19 ARDS Outcomes

COVID Clinical Trial

Official title:

Pulmozyme to Improve COVID-19 ARDS Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402944
• Other study ID #: P00035140
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Boston Children's Hospital
• Contact: Robert Fowler
• Phone: 6173551834
• Email: robert.fowler[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• Pulmozyme
Pulmozyme 2.5 mg BID
• Placebo
Saline 2.5 mL BID

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Brigham and Women's Hospital, South Shore Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days at 28 days	Primary outcome	28 days
Secondary	change in airway resistance	change in airway resistance	28 days
Secondary	change in lung compliance	Change in lung compliance	28 days
Secondary	oxygenation (PaO2/FiO2 ratio)	oxygenation	28 days
Secondary	length of stay (ICU and hospital)	length of stay	28 days
Secondary	rate of barotrauma	rate of batotrauma	28 days
Secondary	mortality.	mortality	28 days