There is one clinical trial.
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 understand the failure of previous clinical trials and yielded a strong
scientific rationale for SRT success, now allowing to design a new administration protocol
for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration
of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of
poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
Primary Outcomes
Measure: Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1). Time: 1 hour post treatment
Secondary Outcomes
Measure: Oxygenation : PaO2 / FiO2 ratio. Time: up to Day 1 and up to Day 7
Measure: Oxygenation : area under the PaO2 / FiO2 curve. Time: up to Day 1 and up to Day 7
Measure: Oxygenation : area under the SpO2 curve. Time: up to Hour 1 and up to Hour 24
Measure: Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure. Time: 1 hour
Measure: Overall survival rate Time: at 28 days, 56 days.
Measure: Mortality rate at discharge from the intensive care unit. Time: through study completion, an average of 6 months.
Measure: Mortality rate at discharge from the hospital. Time: through study completion, an average of 6 months.
Measure: Number of ventilator-free days Time: Day 28, Day 56
Measure: Number of prone position sessions. Time: up to 56 days
Measure: Time between inclusion and the last prone position session. Time: up to 56 days