COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04359654

Joanna Porter, MD PhD

joanna.porter@ucl.ac.uk

2020-04-24

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

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 and/or ild. 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.

2

University College, London

18

100

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

41

Measuring the change in inflammation

None

Phase 2

[{"arm_notes": "", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]