Usefulness of DORNASE in COVID-19 on HFNO

University Medical Centre Ljubljana

Status and phase: Terminated; Phase 4

Conditions: COVID-19 Pneumonia

Treatments: Drug: Dornase Alfa; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05139901

DTS_pulmosyme

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy
• previous treatment with DNAse alfa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

4% saline

Active Comparator group

Description:

4% Saline inhalations twice daily

Treatment:

Drug: Saline

Pulmosyme

Experimental group

Description:

DNAse alpha inhalations twice daily

Treatment:

Drug: Dornase Alfa