Status:

UNKNOWN

Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19

Lead Sponsor:

Dr Christophe LENCLUD

Conditions:

COVID-19

ARDS, Human

Eligibility:

All Genders

18-100 years

Phase:

PHASE2

Brief Summary

Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to un...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.

Key Trial Info

Start Date :

May 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2021

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04384731

Start Date

May 29 2020

End Date

July 31 2021

Last Update

February 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CH Francois Quesnay

Mantes-la-Jolie, France