EUCTR2020-001598-66-FRActive, not recruitingPhase 1
Preliminary randomized controlled trial of poractant alfa (Curosurf®) by fiberoptic bronchoscopy-directed endobronchial administration in acute respiratory distress syndrome (ARDS) due to COVID-19 viral pneumonia. - CAARDS-1
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
- •PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
- •Compliance of the respiratory system < 50 mL/cmH2O
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •Contraindication to prone position.
- •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.
Investigators
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