drugset / Trial / NCT04384731

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

NCT04384731

Phase 2 Unknown 20 enrolled Dr Christophe LENCLUD
RandomizedParallel-groupSingle-blindTreatment

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 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.

Timeline

Start
2020-05-29
Primary completion
2021-05-29
Completion
2021-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Poractant alfa Other / unclassified 48 mg/kg Other