COVIDPhase 2NCT04402944
Pulmozyme to Improve COVID-19 ARDS Outcomes
A Phase 2 study testing Pulmozyme in people with COVID, run by Boston Children's Hospital at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Pulmozyme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jul 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Benjamin Raby, MD
Robert Fowler, 6173551834, robert.fowler@childrens.harvard.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Rebecca Baron, MD
Katherin Alejandra Zamrano Vera, 617-525-7540, mailto:kzambranovera@bwh.harvard.edu
- Recruiting
South Shore Hospital
Weymouth, Massachusetts, 02190
Stephanie Smith, PhD, 781-624-4369, ssmith3@southshorehealth.org
Dilip Nataraj, MD
About this study
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
- Being tested
- Pulmozyme, Placebo
- Keywords
- Pulmozyme, Pneumonia, ARDS
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulmozymeDrug
Also called Dornase alfa
Pulmozyme 2.5 mg BID
PlaceboDrug
Saline 2.5 mL BID
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Study drug Receives: Drug: Pulmozyme |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days at 28 days
Primary outcome
Measured: 28 days
Secondary outcomes (6)
change in airway resistance
change in airway resistance
Measured: 28 days
change in lung compliance
Change in lung compliance
Measured: 28 days
oxygenation (PaO2/FiO2 ratio)
oxygenation
Measured: 28 days
length of stay (ICU and hospital)
length of stay
Measured: 28 days
rate of barotrauma
rate of batotrauma
Measured: 28 days
mortality.
mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start5 Jul 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, South Shore Hospital
- Responsible party
- Principal investigator, Benjamiin Raby, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402944
- Sponsor's protocol ID
- P00035140
- Status last verified
- Dec 2021
- First submitted
- 12 May 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmozyme to Improve COVID-19 ARDS Outcomes
- ClinicalTrials.gov ID
- NCT04402944
- Acronym / sponsor ID
- P00035140
- Conditions
- COVID
- Keywords
- Pulmozyme, Pneumonia, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, South Shore Hospital
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: PulmozymeStudy drug |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulmozymeAlso: Dornase alfaPulmozyme 2.5 mg BID | Drug | Study Drug |
| PlaceboSaline 2.5 mL BID | Drug | Placebo |
Primary outcome
Ventilator-free days at 28 days
Time frame: 28 days
Primary outcome
6 secondary outcomes
change in airway resistance
Time frame: 28 days
change in lung compliance
Time frame: 28 days
oxygenation (PaO2/FiO2 ratio)
Time frame: 28 days
length of stay (ICU and hospital)
Time frame: 28 days
rate of barotrauma
Time frame: 28 days
mortality.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulmozyme in people with COVID, run by Boston Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Fowler (6173551834, robert.fowler@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days at 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.