NCT05139901

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

November 30, 2021

Last Update Submit

February 21, 2023

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Intubations

    Number of intubations necessary

    7 days

Secondary Outcomes (2)

  • PaO2/FiO2

    7 days

  • inflamation

    7 days

Study Arms (2)

4% saline

ACTIVE COMPARATOR

4% Saline inhalations twice daily

Drug: Saline

Pulmosyme

EXPERIMENTAL

DNAse alpha inhalations twice daily

Drug: Dornase Alfa

Interventions

Dornase AlfaDRUG

inhalations twice daily

Pulmosyme
SalineDRUG

inhalations twice daily

Also known as: 4% Saline
4% saline

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • previous treatment with DNAse alfa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

dornase alfaSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 1, 2021

Study Start

December 1, 2021

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

SL(1)