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

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.

Conditions

• COVID-19
• Acute Respiratory Distress Syndrome

Interventions

DRUG

Dornase Alfa Inhalation Solution [Pulmozyme]

Administered by nebulization, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days

PROCEDURE

standard procedure

Patients will receive the usual care in accordance with good practice.

Sponsors & Collaborators

• University Hospital, Strasbourg, France

  collaborator OTHER

• Centre Hospitalier Régional Metz-Thionville

  collaborator OTHER

• Fondation Ophtalmologique Adolphe de Rothschild

  lead NETWORK

Principal Investigators

• Charles Grégoire, MD · Hôpital Fondation A de Rothschild

• Julien Pottecher, MD · CHRU Strasbourg

• Fabien Lambiotte, MD · CH VALENCIENNES

• Serge Le Tacon, MD · CHR Metz-Thionville

• Marie-Reine Pr Losser · CHRU Nancy

• Pierre Kalfon, MD · CH Chartres

• Vincent Das, MD · CH Montreuil

• Karim Nourdine, MD · Hôpital Drôme Nord

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-21

Primary Completion

2021-12-20

Completion

2021-12-20

Countries

• France

Study Locations