Usefulness of DORNASE in COVID-19 on HFNO

NCT ID: NCT05139901

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomised
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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4% saline

4% Saline inhalations twice daily

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

inhalations twice daily

Pulmosyme

DNAse alpha inhalations twice daily

Group Type EXPERIMENTAL

Dornase Alfa

Intervention Type DRUG

inhalations twice daily

Interventions

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Dornase Alfa

inhalations twice daily

Intervention Type DRUG

Saline

inhalations twice daily

Intervention Type DRUG

Other Intervention Names

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4% Saline

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* previous treatment with DNAse alfa
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Marko Zlicar

Head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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DTS_pulmosyme

Identifier Type: -

Identifier Source: org_study_id

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