COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04384731

Sandrine ROUX

sroux@ch-versailles.fr

2020-05-12

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - at least 18 years - 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 kg - height < 140 cm or height > 190 cm. - profuse bronchorrhea (at least 1 succion per hour during 3 hours). - other significant cause than ards to the respiratory failure. - decision to limit active therapies. - no arterial line in place. - obesity with weight / height ratio > 1 kg / cm. - impossible to give neuromuscular blockers (e.g. drug unavailable owing to global pandemia). - severe chronic respiratory failure with oxygen at home. - other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe chronic cardiac failure). - history of pneumonectomy or pulmonary lobectomy. - patient scheduled for extracorporeal membrane oxygenation. - known hypersensibility to curosurf. - contraindication to bronchial fibroscopy. - person under legal protection.

2

Dr Christophe LENCLUD

18

100

France

Critical disease at enrollment

8: Critical disease at enrollment

20

Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).

None

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"}]