Usefulness of DORNASE in COVID-19 on HFNO
Primary Purpose
COVID-19 Pneumonia
Status
Terminated
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Dornase Alfa
Saline
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Positive SARS-CoV-2 RNA PCR swab
- inflamatory phase of infection
- HFNO
Exclusion Criteria:
- pregnancy
- previous treatment with DNAse alfa
Sites / Locations
- University Medical Centre Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
4% saline
Pulmosyme
Arm Description
4% Saline inhalations twice daily
DNAse alpha inhalations twice daily
Outcomes
Primary Outcome Measures
Intubations
Number of intubations necessary
Secondary Outcome Measures
PaO2/FiO2
Increase in PaO2/FiO2 ratio
inflamation
Reduction of inflamation
Full Information
NCT ID
NCT05139901
First Posted
November 30, 2021
Last Updated
February 21, 2023
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT05139901
Brief Title
Usefulness of DORNASE in COVID-19 on HFNO
Official Title
Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomised
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4% saline
Arm Type
Active Comparator
Arm Description
4% Saline inhalations twice daily
Arm Title
Pulmosyme
Arm Type
Experimental
Arm Description
DNAse alpha inhalations twice daily
Intervention Type
Drug
Intervention Name(s)
Dornase Alfa
Intervention Description
inhalations twice daily
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
4% Saline
Intervention Description
inhalations twice daily
Primary Outcome Measure Information:
Title
Intubations
Description
Number of intubations necessary
Time Frame
7 days
Secondary Outcome Measure Information:
Title
PaO2/FiO2
Description
Increase in PaO2/FiO2 ratio
Time Frame
7 days
Title
inflamation
Description
Reduction of inflamation
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive SARS-CoV-2 RNA PCR swab
inflamatory phase of infection
HFNO
Exclusion Criteria:
pregnancy
previous treatment with DNAse alfa
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Usefulness of DORNASE in COVID-19 on HFNO
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