Efficacy and Safety of aerosolizedDornase Alfa Administration in Patients With COVID19 Induced ARDS (COVIDORNASE)
Status:
Recruiting
Trial end date:
2022-04-21
Target enrollment:
Participant gender:
Summary
This study plans to learn more about the effects of Dornase Alfa in COVID19 (coronavirus
disease of 2019) patients, the medical condition caused by the Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2). Dornase Alfa is a FDA-approved drug for the treatment of
cystic fibrosis, which facilitates mucus clearance by cutting apart neutrophil-derived
extracellular double-stranded DNA. This study intends to define the impact of aerosolized
intra-tracheal Dornase Alfa administration on the severity and progression of acute
respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus
thinner and looser, promoting improved clearance of secretions and reduce extracellular
double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the
lungs.
The study will recruit mechanically ventilated patients hospitalized in ICU who have been
diagnosed with COVID-19 and meet ARDS criteria. It is a prospective, randomized, controlled,
multicentric, open-label clinical trial.
The goal is to recruit 100 patients.
Phase:
Phase 3
Details
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators:
Centre Hospitalier Régional Metz-Thionville University Hospital, Strasbourg, France