Phase 2
N=41
Nebulised Dornase Alfa for Treatment of COVID-19 (Coronavirus Disease 2019)
COVID-19 (Coronavirus Disease 2019) · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT04359654 ↗Enrolled (actual)
41
Serious AEs
25.6%
Results posted
Jan 2025
Primary outcome: Primary: Measuring the Change in Inflammation — 23.23; 34.82 mg/L — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dornase Alfa Inhalation Solution [Pulmozyme] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College, London
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring the Change in Inflammation |
23.23; 34.82 | 0.01 sig |
| SECONDARY Survival at 35 Days |
29; 9 | 0.03 sig |
| SECONDARY Discharge Before 35 Days |
27; 8 | — |
| SECONDARY D-dimer (ug/L) |
570.78; 1656.96 | 0.004 sig |
| SECONDARY Lymphocyte Count (×109/L) |
1.08; 0.87 | 0.021 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Male and female participants, aged ≥ 18 years.
- Participants who are hospitalised for suspected Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or radiological confirmation.
- Participants with stable oxygen saturation (>=94%) on supplementary oxygen
- CRP >= 30 mg/L.
- Participants will have given their written informed consent to participate in the study and are able to comply with instructions and nebuliser.
Exclusion Criteria
- Females who are pregnant, planning pregnancy or breastfeeding.
- Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within the last 3 months before study enrolment.
- Serious condition meeting one of the following:
I. respiratory distress with respiratory rate >=40 breaths/min II. oxygen saturation <=93% on high-flow oxygen
- Require mechanical invasive or non-invasive ventilation at screening
- Concurrent severe respiratory disease such as asthma, COPD (chronic obstructive pulmonary disease) and/or ILD (interstitial lung disease).
- Any major disorder that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the study participant.
- Terminal disease and life expectancy <12 months without COVID-19.
- Known allergies to the dornase alfa and excipients.
- Participants who are unable to inhale or exhale orally throughout the entire nebulisation period.
Data sourced from ClinicalTrials.gov (NCT04359654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.