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The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)

COVID-19 Clinical Trial

Official title:
A Multicenter, Single-Treatment Study to Assess the Safety and Tolerability of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury

Clinical Trial Summary

This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.

Clinical Trial Description

This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment. Lucinactant is a synthetic surfactant that, in its liquid form (SURFAXIN®), is approved by the United States Food and Drug Administration (NDA 021746) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. It has been studied in over 2000 children and adults. Preliminary data from animal and adult human studies indicate that lucinactant may be able to benefit those with acute respiratory distress syndrome (ARDS) in the context of COVID-19 infection, improving oxygenation and lung compliance. When given to intubated patients, Lucinactant could potentially decrease the duration of ventilation. Lucinactant has an extensive safety profile in different patient populations for different indications. It is hypothesized that lucinactant may improve the respiratory status of patients suffering from COVID-19. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04389671
Study type Interventional
Source Windtree Therapeutics
Contact
Status Completed
Phase Phase 2
Start date January 5, 2021
Completion date February 20, 2022
View Details
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