COVID-19Phase 2NCT04541979
Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19
A Phase 2 study testing aerosolized DNase and NaCl in people with COVID-19, run by Region Skane at 1 site in Sweden.
Trial summary
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- aerosolized DNase and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- 4 Jun 2020to 6 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Admitted to hospital ward or ICU
- A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx
- An oxygen saturation ≤90% after maximum 15 minutes without supplemental oxygen
- Signed informed consent
Who cannot join
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Known or suspected allergy against Pulmozyme
- Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease
- Participation in a clinical study with an investigational product during the last 30 days
- Previous participation in this study
- Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period
- Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient's compliance with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
Read the detailed description
Study objectives: Primary objective: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy or discharge from hospital in hospitalized patients with COVID-19 and respiratory dysfunction.
Secondary objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on 28-day mortality, days alive and without ventilator treatment, days alive and without high flow nasal oxygen treatment (Optiflow), length of stay in the ICU, days alive and outside hospital, relapse of hypoxia, days alive and without need for supplemental oxygen, adverse reactions.
Exploratory objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 9%) on quantification of NETs in respiratory secretions and on the incidence of clinical thromboembolic events.
Study design: Phase 2 open-label randomized controlled multicentre trial. The study period is 28 days from randomization. A long term follow-up on mortality and readmission will also be collected via patient medical records/registries at day 90, day 180, and day 360 after randomization.
- Conditions
- COVID-19
- Being tested
- aerosolized DNase, NaCl
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosolized DNaseDrug
DNase
NaClDrug
NaCl 0.9%, isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Aerosolized DNase I | Active comparator | Not described Receives: Drug: aerosolized DNase |
| NaCl | Placebo comparator | Not described Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction.
Number of Days to cessation of oxygen therapy after start of treatment
Measured: 28 days
Secondary outcomes (8)
28-day mortality
Number of diseased patients up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and without ventilator treatment
Number of Days alive and without ventilator treatment up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and without high flow nasal oxygen treatment (Optiflow)
Number of Days alive and without high flow nasal oxygen treatment (Optiflow) up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and free of stay in the ICU
Number of Days alive and free of stay in the ICU up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and outside hospital
Number of Days alive and outside hospital up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met
Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met up to 28 Days after start of treatment
Measured: 28 days
Number of Days alive and without need of supplemental oxygen
Number of Days alive and without need of supplemental oxygen up to 28 Days after start of treatment
Measured: 28 days
Number of patients with adverse reactions
Number of patients with adverse reactions reported up to 28 Days after start of treatment
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 posted9 Sep 2020
- Study start4 Jun 2020
- Primary completion11 Jan 2022
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Linder, Region Skane
- Investigators
- Adam Linder, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541979
- Sponsor's protocol ID
- NETSC-19
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: nn
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 - a Phase 2, Single-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT04541979
- Acronym / sponsor ID
- NETSC-19
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 9 Sep 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.
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
Detailed description
Study objectives: Primary objective: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy or discharge from hospital in hospitalized patients with COVID-19 and respiratory dysfunction.
Secondary objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on 28-day mortality, days alive and without ventilator treatment, days alive and without high flow nasal oxygen treatment (Optiflow), length of stay in the ICU, days alive and outside hospital, relapse of hypoxia, days alive and without need for supplemental oxygen, adverse reactions.
Exploratory objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 9%) on quantification of NETs in respiratory secretions and on the incidence of clinical thromboembolic events.
Study design: Phase 2 open-label randomized controlled multicentre trial. The study period is 28 days from randomization. A long term follow-up on mortality and readmission will also be collected via patient medical records/registries at day 90, day 180, and day 360 after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosolized DNase I | Active comparator | Drug: aerosolized DNase |
| NaCl | Placebo comparator | Drug: NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old
- Admitted to hospital ward or ICU
- A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx
- An oxygen saturation ≤90% after maximum 15 minutes without supplemental oxygen
- Signed informed consent
Key exclusion criteria (7 listed)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Known or suspected allergy against Pulmozyme
- Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease
- Participation in a clinical study with an investigational product during the last 30 days
- Previous participation in this study
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 |
|---|---|---|
| aerosolized DNaseDNase | Drug | Aerosolized DNase I |
| NaClNaCl 0.9%, isotonic saline | Drug | NaCl |
Primary outcome
Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction.
Time frame: 28 days
Number of Days to cessation of oxygen therapy after start of treatment
8 secondary outcomes
28-day mortality
Time frame: 28 days
Number of Days alive and without ventilator treatment
Time frame: 28 days
Number of Days alive and without high flow nasal oxygen treatment (Optiflow)
Time frame: 28 days
Number of Days alive and free of stay in the ICU
Time frame: 28 days
Number of Days alive and outside hospital
Time frame: 28 days
Number of Days alive and free of a new episode and with oxygen saturation ≤93% after primary endpoint has been met
Time frame: 28 days
Number of Days alive and without need of supplemental oxygen
Time frame: 28 days
Number of patients with adverse reactions
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided. nn
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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.
Adam Linder, MD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aerosolized DNase and NaCl in people with COVID-19, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction. (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 6 Aug 2024.