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

NCT04359654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-01-13

Study results available
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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

Interventions

DRUG

Dornase Alfa Inhalation Solution [Pulmozyme]

Nebulised Dornase alfa 2.5mg bd for 7 days

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Joanna Porter, MD PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2021-08-12
Completion
2021-11-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359654 on ClinicalTrials.gov