Curosurf® in Adult Acute Respiratory Distress Syndrome – 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001598-66-FR

Enrollment

Registered

2020-04-16

Start date

2020-05-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome due to COVID-19 viral pneumonia

Interventions

Trade Name: Curosurf Pharmaceutical Form: Endotracheopulmonary instillation

Eligibility

Sex/Gender

All

Inclusion criteria

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. COVID-19 PaO2/FiO2 ratio =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): • Evolution of oxygenation and respiratory state (PaO2, PaO2 / FiO2, SaO2, lung compliance, chest x-ray) and its chronology following the procedure. • Number of ventral decubitus sessions and date of the last session. • Withdrawal time from artificial ventilation, expressed in "free days of artificial ventilation". • Survival at 28 days, 56 days, after discharge from the intensive care unit, after discharge from the hospital.	—

Measure

Time frame

Secondary end point(s): • Evolution of oxygenation and respiratory state (PaO2, PaO2 / FiO2, SaO2, lung compliance, chest x-ray) and its chronology following the procedure. • Number of ventral decubitus sessions and date of the last session. • Withdrawal time from artificial ventilation, expressed in "free days of artificial ventilation". • Survival at 28 days, 56 days, after discharge from the intensive care unit, after discharge from the hospital.

—

Primary

Measure	Time frame
Main Objective: To show that the drug as used in this procedure improves blood oxygenation (PaO2/FiO2). ;Secondary Objective: To assess the impact of this procedure on improving the respiratory state and its duration: oxygenation, weaning time from mechanical ventilation, survival.;Primary end point(s): Primary outcome: PaO2 / FiO2 ratio increase between before and one hour after procedure.	—

Countries

France

Contacts

Public ContactSandrine ROUX

Centre Hospitalier de Versailles

sroux@ch-versailles.fr+33139239777

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026