NCT04389671

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID-19
• Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DRUG	Lucinactant	Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-02-20
• Completion: 2022-02-20
• First posted: 2020-05-15
• Last updated: 2023-06-23
• Results posted: 2023-06-23

Locations

11 sites across 2 countries: United States, Argentina

Regulatory

• FDA-regulated drug study