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Clinical Trials/NCT05139901
NCT05139901
Terminated
Phase 4

Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy

University Medical Centre Ljubljana1 site in 1 country10 target enrollmentDecember 1, 2021

Overview

Phase
Phase 4
Intervention
Saline
Conditions
COVID-19 Pneumonia
Sponsor
University Medical Centre Ljubljana
Enrollment
10
Locations
1
Primary Endpoint
Intubations
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
February 22, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marko Zlicar

Head of department

University Medical Centre Ljubljana

Eligibility Criteria

Inclusion Criteria

  • Positive SARS-CoV-2 RNA PCR swab
  • inflamatory phase of infection

Exclusion Criteria

  • pregnancy
  • previous treatment with DNAse alfa

Arms & Interventions

4% saline

4% Saline inhalations twice daily

Intervention: Saline

Pulmosyme

DNAse alpha inhalations twice daily

Intervention: Dornase Alfa

Outcomes

Primary Outcomes

Intubations

Time Frame: 7 days

Number of intubations necessary

Secondary Outcomes

  • PaO2/FiO2(7 days)
  • inflamation(7 days)

Study Sites (1)

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