Efficacy and Safety of aerosolizedDornase Alfa Administration in Patients With COVID19 Induced ARDS (COVIDORNASE)

• Status: Recruiting
• Trial end date: 2022-04-21
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Centre Hospitalier Régional Metz-Thionville; University Hospital, Strasbourg, France

Criteria

inclusion criteria

• Adult patient (age ≥ 18 years old);

• Hospitalized in intensive care ;

• Severe COVID-19 pneumonia (positive diagnosis by RT-PCR or SARS-CoV-2 antigen test on nasopharyngeal or deep respiratory specimen and/or evocative thoracic scan: frosted glass opacities, consolidation, cross-linking, thickening of interlobular septa, peripheral nodules) with ARDS criteria according to Berlin criteria (PaO2/FiO2 ≤ 300 and PEP ≥ 5).

• With respiratory assistance (intubated or NIV or ONHD) for less than 8 days;

• With an expected duration of respiratory assistance > 48 hours;

• Carrier of an arterial catheter ;

• For which 4 PaO2/FiO2 values on arterial blood over the last 24 hours are available;

Exclusion Criteria:

• Known hypersensitivity to Dornase alfa or any of the excipients;

• Pregnant or breastfeeding status;

• Patient with legal protection.