Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04452669
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2020-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation
Sponsor:
Aerogen Pharma Limited
Organization:
Study Overview
Official Title:
Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VPCOVID
Brief Summary:
The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.
Detailed Description:
This study will evaluate the potential therapeutic benefit of VentaProst in treating patients with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst given over 10 days at varying doses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: