Usefulness of DORNASE in COVID-19 on HFNO | NCT05139901

Studies
Usefulness of DORNASE in COVID-19 on HFNO

NCT05139901

Sponsor

University Medical Centre Ljubljana

Status

Terminated

Last Update Posted

Feb 23, 2023Actual

Enrollment

10Actual

Phase

Phase 4

Conditions

COVID-19 Pneumonia

Interventions

Dornase Alfa
Saline

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Feb 22, 2023Actual

Completion Date

Feb 22, 2023Actual

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4% saline	Active Comparator	4% Saline inhalations twice daily	Drug: Saline
Pulmosyme	Experimental	DNAse alpha inhalations twice daily	Drug: Dornase Alfa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dornase Alfa	Drug	inhalations twice daily	Pulmosyme
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubations	Number of intubations necessary	7 days

Secondary Outcomes

Measure	Description	Time Frame
PaO2/FiO2	Increase in PaO2/FiO2 ratio	7 days
inflamation	Reduction of inflamation	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy
previous treatment with DNAse alfa

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C568813	dornase alfa
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided