Usefulness of DORNASE in COVID-19 on HFNO

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05139901
Collaborator
(none)
60
2
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind randomisedDouble blind randomised
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 4% saline

4% Saline inhalations twice daily

Drug: Saline
inhalations twice daily
Other Names:
  • 4% Saline
  • Experimental: Pulmosyme

    DNAse alpha inhalations twice daily

    Drug: Dornase Alfa
    inhalations twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Intubations [7 days]

      Number of intubations necessary

    Secondary Outcome Measures

    1. PaO2/FiO2 [7 days]

      Increase in PaO2/FiO2 ratio

    2. inflamation [7 days]

      Reduction of inflamation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Positive SARS-CoV-2 RNA PCR swab

    • inflamatory phase of infection

    • HFNO

    Exclusion Criteria:
    • pregnancy

    • previous treatment with DNAse alfa

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Medical Centre Ljubljana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marko Zlicar, Head of department, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT05139901
    Other Study ID Numbers:
    • DTS_pulmosyme
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2021