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NCT05139901 Clinical Trial

Usefulness of DORNASE in COVID-19 on HFNO

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05139901
Other study ID # DTS_pulmosyme
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date December 1, 2021
Est. completion date February 22, 2023

Study information
Verified date February 2023
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date February 22, 2023
Est. primary completion date February 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Positive SARS-CoV-2 RNA PCR swab - inflamatory phase of infection - HFNO Exclusion Criteria: - pregnancy - previous treatment with DNAse alfa

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dornase Alfa
inhalations twice daily
• Saline
inhalations twice daily

Locations
Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intubations Number of intubations necessary 7 days
Secondary PaO2/FiO2 Increase in PaO2/FiO2 ratio 7 days
Secondary inflamation Reduction of inflamation 7 days
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