COVID-19 PneumoniaPhase 4NCT05139901
Usefulness of DORNASE in COVID-19 on HFNO
A Phase 4 study testing Dornase Alfa and Saline in people with COVID-19 Pneumonia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Dornase Alfa and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2021to 22 Feb 2023
- Phase
- Phase 4
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive SARS-CoV-2 RNA PCR swab
- inflamatory phase of infection
- HFNO
Who cannot join
- pregnancy
- previous treatment with DNAse alfa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Dornase Alfa, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dornase AlfaDrug
inhalations twice daily
SalineDrug
Also called 4% Saline
inhalations twice daily
| Study group | Role | What they receive |
|---|---|---|
| 4% saline | Active comparator | 4% Saline inhalations twice daily Receives: Drug: Saline |
| Pulmosyme | Experimental | DNAse alpha inhalations twice daily Receives: Drug: Dornase Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubations
Number of intubations necessary
Measured: 7 days
Secondary outcomes (2)
PaO2/FiO2
Increase in PaO2/FiO2 ratio
Measured: 7 days
inflamation
Reduction of inflamation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2021
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Why it stopped: Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomised
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Zlicar, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139901
- Sponsor's protocol ID
- DTS_pulmosyme
- Status last verified
- Feb 2023
- First submitted
- 30 Nov 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
- ClinicalTrials.gov ID
- NCT05139901
- Acronym / sponsor ID
- DTS_pulmosyme
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 1 Dec 2021 (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.
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomised
| Arm | Type | Receives |
|---|---|---|
| 4% saline | Active comparator | Drug: Saline4% Saline inhalations twice daily |
| Pulmosyme | Experimental | Drug: Dornase AlfaDNAse alpha inhalations twice daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive SARS-CoV-2 RNA PCR swab
- inflamatory phase of infection
- HFNO
Key exclusion criteria (2 listed)
- pregnancy
- previous treatment with DNAse alfa
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 |
|---|---|---|
| Dornase Alfainhalations twice daily | Drug | Pulmosyme |
| SalineAlso: 4% Salineinhalations twice daily | Drug | 4% saline |
Primary outcome
Intubations
Time frame: 7 days
Number of intubations necessary
2 secondary outcomes
PaO2/FiO2
Time frame: 7 days
inflamation
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dornase Alfa and Saline in people with COVID-19 Pneumonia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubations (time frame: 7 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 23 Feb 2023.