Status:
TERMINATED
Efficacy and Safety of aerosolizedDornase Alfa Administration in Patients With COVID19 Induced ARDS (COVIDORNASE)
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
University Hospital, Strasbourg, France
Centre Hospitalier Régional Metz-Thionville
Conditions:
COVID-19
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Acute Respiratory Distress Syndrome (ARDS) is the most severe form of COVID-19 with a mortality reaching 50%. To date, no specific therapy has been shown to be effective. During an acute viral respira...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04355364
Start Date
April 21 2020
End Date
December 20 2021
Last Update
January 11 2022
Active Locations (1)
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1
Hôpital Fondation A. de Rotschhild
Paris, France