COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001492-33/FR

Hôpital Fondation Adolphe de Rothschild - Clinical Research Director

pvachey@for.paris

2020-04-01

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- Major patient (age ≥ 18 years old), - Hospitalized in intensive care, - Severe pneumonia COVID-19 with Berlin criteria for ARDS (PaO2/FiO2<300 and PEP>5). - Intubated for less than 8 days , - Expected duration of mechanical ventilation is >48 hours, - Carrying an arterial catheter, - Affiliated with or beneficiary of a health insurance social protection scheme - Patient majeur (âge ≥ 18 ans) , - Hospitalisé en réanimation , - Atteint d’une pneumonie grave COVID-19 avec critères de SDRA selon les critères de Berlin (PaO2/FiO2<300 et PEP>5). - Intubé depuis moins de 8 jours , - Dont la durée prévisible de ventilation mécanique est > 48h , - Porteur d’un cathéter artériel , - Affilié ou bénéficiaire d’un régime de protection sociale d’assurance maladie

- Known hypersensitivity to Dornase alfa or any of the excipients, - Pregnant or nursing woman, - Patient with legal pro - Hypersensibilité connue à la Dornase alfa ou à l’un des excipients , - Femme enceinte ou allaitant , - Patient bénéficiant d’une mesure de protection juridique

2

Hôpital Fondation Adolphe de Rothschild

18

None

France

Severe disease at enrollment

6: Severe disease at enrollment

100

Comparison between the two treatment arms of the evolution of the PaO2/FiO2 ratio between D0 (inclusion) and D7 Comparaison entre les deux bras de traitement de l’évolution du rapport PaO2/FiO2 entre J0 (inclusion) et J7

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]