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

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).

Timeline

Start

2020-06-16

Primary completion

2021-08-12

Completion

2021-11-05

Publications

• 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.

Drugs

Indications