Nebulised Dornase Alfa for Treatment of COVID-19 (Coronavirus Disease 2019)

NCT04359654 | Completed Phase 2 Results DMC

• 1 other identifier: 132333
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19 (Coronavirus Disease 2019); Hypoxia

Keywords

COVID; COVID19; Pneumonia; Coronavirus; Hypoxia; C-Reactive Protein

Outcome Measures

Primary Outcomes (1)

• Measuring the Change in Inflammation

  Analysing stabilisation of C-reactive protein.

  7 days

Secondary Outcomes (4)

• Survival at 35 Days

  35 days

• Discharge Before 35 Days

  Before 35 days

• D-dimer (ug/L)

  7 days

• Lymphocyte Count (×109/L)

  7 days

Study Arms (2)

Dornase alfa treatment

EXPERIMENTAL

Best available care and nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure

Drug: Dornase Alfa Inhalation Solution [Pulmozyme]

Best available care

NO INTERVENTION

Best available standard of care

Interventions

Dornase Alfa Inhalation Solution [Pulmozyme] DRUG

Nebulised Dornase alfa 2.5mg bd for 7 days

Dornase alfa treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

• Porter JC, Inshaw J, Solis VJ, Denneny E, Evans R, Temkin MI, De Vasconcelos N, Aramburu IV, Hoving D, Basire D, Crissell T, Guinto J, Webb A, Esmail H, Johnston V, Last A, Rampling T, Lippert L, Helbig ET, Kurth F, Williams B, Flynn A, Lukey PT, Birault V, Papayannopoulos V. Anti-inflammatory therapy with nebulized dornase alfa for severe COVID-19 pneumonia: a randomized unblinded trial. Elife. 2024 Jul 16;12:RP87030. doi: 10.7554/eLife.87030.

  PMID: 39009040 DERIVED

MeSH Terms

Conditions

COVID-19; Hypoxia; Pneumonia; Coronavirus Infections

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ms Donna Basire
• Organization: University College London

d.basire@ucl.ac.uk

+44-2031087748

Study Officials

• Joanna Porter, MD PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label, randomised, Best-Available-Care (BAC) and historic-controlled trial of nebulised dornase alfa \[2.5 mg BID\] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: June 16, 2020
• Primary Completion: August 12, 2021
• Study Completion: November 5, 2021
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)