CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Dornase Alfa Inhalation Solution [Pulmozyme]drug
Likely dose
Dornase Alfa Inhalation Solution [Pulmozyme] 2.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04359654
NCT04359654Phase 2Completed

A Single-site, Randomised, Controlled, Parallel Design, Open-label Investigation of an Approved Nebulised Recombinant Human DNase Enzyme (Dornase Alfa) to Reduce Hyperinflammation in Hospitalised Participants With COVID-19

University College, London·interventional·Posted Apr 24, 2020·Updated Jan 13, 2025

In Brief

A Phase 2 clinical trial evaluating Dornase Alfa Inhalation Solution [Pulmozyme] for COVID-19 (Coronavirus Disease 2019) and Hypoxia. Completed, enrolled 41 participants across 1 site.

Detailed Summary

An open-label, randomised, Best-Available-Care (BAC) and historic-controlled trial of nebulised dornase alfa \[2.5 mg BID (bis in die)\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure (the COVASE study). Controls will include a randomised arm to receive BAC, historic data from University College London Hospitals NHS Foundation Trust (UCLH) patients with COVID-19 and biobanked samples will be used to demonstrate an effect of dornase alfa. C-reactive protein (CRP) will be measured to assess the effect of dornase alfa on inflammation. Clinical endpoints and biomarkers (e.g. d-dimer) will be used to assess the clinical response. Exploratory endpoints will explore the effects of dornase alfa on features of neutrophil extracellular traps (NETs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartJun 16, 2020
Primary CompletionAug 12, 2021
Study CompletionNov 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.2 years ago

Interventions

Dornase Alfa Inhalation Solution [Pulmozyme]drug

Nebulised Dornase alfa 2.5mg bd for 7 days