COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001598-66/FR

Centre Hospitalier de Versailles - Sandrine ROUX

sroux@ch-versailles.fr

2020-04-16

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

At least 18 years and less than 75 years old. Intensive care unit admission. Intubation and mechanical ventilation since less than 72h. Positive end-expiratory pressure ≥ 5 cmH2O. Acute respiratory distress syndrome following Berlin definition. COVID-19 PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial. Compliance of the respiratory system < 50 mL/cmH2O

Contraindication to prone position. Pregnancy. Weight < 40 kgs Height below 140 cm or above 190 cm. Profuse bronchorrhea Other significant cause than ARDS to the respiratory failure History of pneumonectomy or pulmonary lobectomy Limitation of therapeutics. No arterial line in place. Impossible to give neuromuscular blockers (e.g. drug unavailable). Severe chronic respiratory failure with oxygen at home. Other severe acute or chronic liver failure Patient scheduled for extracorporeal membrane oxygenation. Known hypersensibility to Curosurf.

2

Centre Hospitalier de Versailles

18

75

France

Critical disease at enrollment

8: Critical disease at enrollment

20

Primary outcome: PaO2 / FiO2 ratio increase between before and one hour after procedure.

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

Phase 2

[{"arm_notes": "", "treatment_id": 1011, "treatment_name": "Poractant 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"}]