Nebulised Dornase Alfa for Treatment of COVID-19

• Status: Completed
• Trial end date: 2021-11-05
• Target enrollment: 0
• Participant gender: All

Summary

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 (the COVASE study). Controls will include a randomised arm to receive BAC, historic data from UCLH patients with COVID-19 and biobanked samples will be used to demonstrate an effect of dornase alfa. 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London

Criteria

Inclusion Criteria:

1. Male and female participants, aged ≥ 18 years.

2. Participants who are hospitalised for suspected Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or radiological confirmation.

3. Participants with stable oxygen saturation (>=94%) on supplementary oxygen

4. CRP >= 30 mg/L.

5. Participants will have given their written informed consent to participate in the study and are able to comply with instructions and nebuliser.

Exclusion Criteria:

1. Females who are pregnant, planning pregnancy or breastfeeding.

2. 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.

3. Serious condition meeting one of the following:

I. respiratory distress with respiratory rate >=40 breaths/min II. oxygen saturation <=93% on high-flow oxygen

4. Require mechanical invasive or non-invasive ventilation at screening

5. Concurrent severe respiratory disease such as asthma, COPD and/or ILD.

6. 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.

7. Terminal disease and life expectancy <12 months without COVID-19.

8. Known allergies to the dornase alfa and excipients.

9. Participants who are unable to inhale or exhale orally throughout the entire nebulisation period.