Dornase Alpha for the Treatment of COVID-19
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Pulmozyme
Sponsored by

About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Dornase Alpha
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant and / or breastfeeding women.
- Any known allergy to Dornase Alpha
- Being involved in another drug study
- Previously diagnosed with chronic lung disease
Sites / Locations
- Acıbadem Altunizade HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Newly Diagnosed Patient Group (n=30)
Patient Group Monitored by Mechanical Ventilation (n=30)
Arm Description
I. Dornase Alpha treated group (n=15) ii. Control group (n=15)
I. Dornase Alpha treated group (n=15) ii. Control group (n=15)
Outcomes
Primary Outcome Measures
Response
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)
Secondary Outcome Measures
Survival
Death
Full Information
NCT ID
NCT04432987
First Posted
June 15, 2020
Last Updated
June 15, 2020
Sponsor
Acibadem University
Collaborators
The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT04432987
Brief Title
Dornase Alpha for the Treatment of COVID-19
Official Title
Determination of Dornase Alpha Effectiveness in COVID-19 Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
August 25, 2020 (Anticipated)
Study Completion Date
September 25, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University
Collaborators
The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Dornase Alpha
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Newly Diagnosed Patient Group (n=30)
Arm Type
Experimental
Arm Description
I. Dornase Alpha treated group (n=15)
ii. Control group (n=15)
Arm Title
Patient Group Monitored by Mechanical Ventilation (n=30)
Arm Type
Experimental
Arm Description
I. Dornase Alpha treated group (n=15)
ii. Control group (n=15)
Intervention Type
Drug
Intervention Name(s)
Pulmozyme
Intervention Description
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
Primary Outcome Measure Information:
Title
Response
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Survival
Description
Death
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnant and / or breastfeeding women.
Any known allergy to Dornase Alpha
Being involved in another drug study
Previously diagnosed with chronic lung disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ercument Ovalı, MD
Phone
+905325729174
Email
ercument.ovali@acibadem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercument Ovalı, MD
Organizational Affiliation
Acıbadem Labcell Cellular Therapy Laboratories
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem Altunizade Hospital
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ercument Ovalı, Prof.
Phone
+905325729174
Email
ercument.ovali@acibademlabcell.com.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dornase Alpha for the Treatment of COVID-19
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