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

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..

Medienart:

Klinische Studie

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

ClinicalTrials.gov - (2023) vom: 23. Juni Zur Gesamtaufnahme - year:2023

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Acute Lung Injury
COVID-19
Lung Injury
Phase: Phase 2
Recruitment Status: Completed
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Study Type: Interventional

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: May 15, 2020, Last downloaded: ClinicalTrials.gov processed this data on June 28, 2023, Last updated: June 28, 2023

Study ID:

NCT04389671
02-CL-2001a

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG003392813