Status:
COMPLETED
Nebulised Dornase Alfa for Treatment of COVID-19 (Coronavirus Disease 2019)
Lead Sponsor:
University College, London
Conditions:
COVID-19 (Coronavirus Disease 2019)
Hypoxia
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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 ho...
Detailed Description
Dornase alfa is a recombinant human DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) to improve pulmonary function. Dornase alfa degrades extrac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04359654
Start Date
June 16 2020
End Date
November 5 2021
Last Update
January 13 2025
Active Locations (1)
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1
University College London Hospital
London, United Kingdom, NW1 2BU