NCT04452669

VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Aerogen Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)	VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition.

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2020-06-30
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study