COVID-19Phase 2NCT04432987
Dornase Alpha for the Treatment of COVID-19
A Phase 2 study testing Pulmozyme in people with COVID-19, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately. 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?
- Pulmozyme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2020to 25 Sep 2020
- 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
- Being 18 or older
- Approving the Informed Consent Form
- Being diagnosed with COVID-19 with PCR and / or radiological clinical findings
- Hospitalization indication according to Ministry of Health criteria
Who cannot join
- Pregnant and / or breastfeeding women.
- Any known allergy to Dornase Alpha
- Being involved in another drug study
- Previously diagnosed with chronic lung disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Altunizade Hospital
Istanbul, 34662
Ercument Ovalı, Prof., +905325729174, ercument.ovali@acibademlabcell.com.tr
About this study
Official title: Determination of Dornase Alpha Effectiveness in COVID-19 Treatment
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.
Read the detailed description
Recent studies confirmed the role of immune hyperactivation in the pathogenesis of COVID-19. Immune cells, especially neutrophils, infiltrate pulmonary capillaries that cause acute fibrin deposition and extravasation into the alveolar space. This excessive accumulation of neutrophils constitutes NETs which makes the mucus thick and viscous. The highly viscous mucus lowers the patient's respiratory function and impairs ventilation supporting NETs may play a major role in the disease. As a mechanism, double-stranded DNA constitutes the backbone of NETs and Dornase alfa promotes the clearance of NETs from plasma neutralization. Endogenous Deoxyribonucleases (DNases), which physiologically break up this extracellular DNA, may become overwhelmed by a massive influx of NETs. Clinically, recombinant human DNase I (rhDNase, Dornase Alfa) has the identical primary amino acid sequence with the native human enzyme and has been approved for the management of cystic fibrosis. Daily administration of dornase alfa is effective in the treatment of cystic fibrosis patients improving pulmonary functions. The similarity of mucus secretions in COVID-19 and cystic fibrosis patients by the means of NETs makes Dornase alfa as a therapeutic option in COVID-19.
Progressive COVID-19 pneumonia may be mortal if it is not treated early, causing respiratory failure. The most important factor leading to respiratory failure is hyaline membrane formed by a neutrophil trap that develops in the cavities of the alveoli. Dornase Alpha is thought to have an important contribution by the lysis of this hyalen membrane. In this study, it is aimed to evaluate the effectiveness of Dornase Alpha treatment in case of early and late use in COVID-19 disease.
Patients diagnosed with COVID-19 PCR and / or radiological-clinical findings is included in the study, and this treatment is carried out in 2 patient groups in comparison with the control groups. The groups are:
- Newly Diagnosed Patient Group I. Dornase Alpha treated group ii. Control group
- Patient Group Monitored by Mechanical Ventilation I. Dornase Alpha treated group ii. Control group
- Conditions
- COVID-19
- Being tested
- Pulmozyme
- Keywords
- COVID-19, Dornase Alpha
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulmozymeDrug
PULMOZYME contains an active substance called dornase alpha as an active substance. Dornase alpha is a human-made version of a protein called DNase in your body and is also known as recombinant human deoxyribonuclease 1 or rhDNase.
Drug will be administered at a dose of 2,5 mg/2 times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed Patient Group (n=30) | Experimental | I. Dornase Alpha treated group (n=15)
ii. Control group (n=15) Receives: Drug: Pulmozyme |
| Patient Group Monitored by Mechanical Ventilation (n=30) | Experimental | I. Dornase Alpha treated group (n=15)
ii. Control group (n=15) Receives: Drug: Pulmozyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
- The patient has no complaints (cough and dyspnea completely disappear, the number of breaths are in the age-appropriate range, oxygen saturation is in the normal range), inflammatory markers in blood improve (CRP, LDH, Ferritin and D-Dimer regression to the reference range). ii. Extubation (for mechanically ventilated group) iii. Intubated (for newly diagnosed group)
Measured: 3 months
Secondary outcomes (1)
Survival
Death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start25 May 2020
- Primary completion25 Aug 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
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 Acibadem UniversityThe 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Ercument Ovalı, MD, Principal investigator, Acıbadem Labcell Cellular Therapy Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432987
- Sponsor's protocol ID
- 8820
- Status last verified
- May 2020
- First submitted
- 15 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dornase Alpha Effectiveness in COVID-19 Treatment
- ClinicalTrials.gov ID
- NCT04432987
- Acronym / sponsor ID
- 8820
- Conditions
- COVID-19
- Keywords
- COVID-19, Dornase Alpha
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 Aug 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 16 Jun 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.
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.
Detailed description
Recent studies confirmed the role of immune hyperactivation in the pathogenesis of COVID-19. Immune cells, especially neutrophils, infiltrate pulmonary capillaries that cause acute fibrin deposition and extravasation into the alveolar space. This excessive accumulation of neutrophils constitutes NETs which makes the mucus thick and viscous. The highly viscous mucus lowers the patient's respiratory function and impairs ventilation supporting NETs may play a major role in the disease. As a mechanism, double-stranded DNA constitutes the backbone of NETs and Dornase alfa promotes the clearance of NETs from plasma neutralization. Endogenous Deoxyribonucleases (DNases), which physiologically break up this extracellular DNA, may become overwhelmed by a massive influx of NETs. Clinically, recombinant human DNase I (rhDNase, Dornase Alfa) has the identical primary amino acid sequence with the native human enzyme and has been approved for the management of cystic fibrosis. Daily administration of dornase alfa is effective in the treatment of cystic fibrosis patients improving pulmonary functions. The similarity of mucus secretions in COVID-19 and cystic fibrosis patients by the means of NETs makes Dornase alfa as a therapeutic option in COVID-19.
Progressive COVID-19 pneumonia may be mortal if it is not treated early, causing respiratory failure. The most important factor leading to respiratory failure is hyaline membrane formed by a neutrophil trap that develops in the cavities of the alveoli. Dornase Alpha is thought to have an important contribution by the lysis of this hyalen membrane. In this study, it is aimed to evaluate the effectiveness of Dornase Alpha treatment in case of early and late use in COVID-19 disease.
Patients diagnosed with COVID-19 PCR and / or radiological-clinical findings is included in the study, and this treatment is carried out in 2 patient groups in comparison with the control groups. The groups are:
- Newly Diagnosed Patient Group I. Dornase Alpha treated group ii. Control group
- Patient Group Monitored by Mechanical Ventilation I. Dornase Alpha treated group ii. Control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Patient Group (n=30) | Experimental | Drug: PulmozymeI. Dornase Alpha treated group (n=15) ii. Control group (n=15) |
| Patient Group Monitored by Mechanical Ventilation (n=30) | Experimental | Drug: PulmozymeI. Dornase Alpha treated group (n=15) ii. Control group (n=15) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 or older
- Approving the Informed Consent Form
- Being diagnosed with COVID-19 with PCR and / or radiological clinical findings
- Hospitalization indication according to Ministry of Health criteria
Key exclusion criteria (4 listed)
- Pregnant and / or breastfeeding women.
- Any known allergy to Dornase Alpha
- Being involved in another drug study
- Previously diagnosed with chronic lung disease
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 |
|---|---|---|
| PulmozymePULMOZYME contains an active substance called dornase alpha as an active substance. Dornase alpha is a human-made version of a protein called DNase in your body and is also known as recombinant human deoxyribonuclease 1 or rhDNase. Drug will be administered at a dose of 2,5 mg/2 times per day for 7 days | Drug | Newly Diagnosed Patient Group (n=30), Patient Group Monitored by Mechanical Ventilation (n=30) |
Primary outcome
Response
Time frame: 3 months
i. The patient has no complaints (cough and dyspnea completely disappear, the number of breaths are in the age-appropriate range, oxygen saturation is in the normal range), inflammatory markers in blood improve (CRP, LDH, Ferritin and D-Dimer regression to the reference range). ii. Extubation (for mechanically ventilated group) iii. Intubated (for newly diagnosed group)
1 secondary outcome
Survival
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Ercument Ovalı, MD principal investigator
Acıbadem Labcell Cellular Therapy Laboratories
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 Pulmozyme in people with COVID-19, run by Acibadem University at 1 site in Turkey (Türkiye).
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 4 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 16 Jun 2020. 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 Turkey (Türkiye). 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 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 Ercument Ovalı, MD (+905325729174, ercument.ovali@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 3 months). 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 16 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.