VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

• Registration Number: NCT04452669
• Lead Sponsor: Aerogen Pharma Limited

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 Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-06-30
• Study Start: 2020-09-15
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Confirmed COVID-19 positive by RT-PCR test
• Patients who require invasive mechanical ventilation.
• Consent or professional consent obtained

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Exclusion Criteria

• Patients on ECMO support.
• Patients receiving another inhalation research medication or inhaled nitric oxide.
• Not expected to survive for 48 hours.
• Allergy to Epoprostenol and its diluent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Treatment	VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)	Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
Placebo Control	VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)	Up to 10 days of inhaled 0.9% sodium chloride solution delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.

Primary Outcome Measures

Name	Time	Method
Reduction in Cardiac/Circulatory Failure	10 days	* Number of participants that require ECMO; * Number of participants requiring inotropic therapy; * Number of participants that require mechanical circulatory support; * A change in Cardiac Troponin \>20% from baseline or; * A change in BNP \>15% from baseline
Reduction in Respiratory Failure	10 days	* Number of participants that require ECMO; * Number of participants that cannot be extubated within 10 days or; * A downward change in Oxygenation Index by \>15% from baseline

Secondary Outcome Measures

Name	Time	Method
Improvement in Oxygenation	10 days	Number of participants that demonstrate a change in FiO2 by 50% or more.
Improved Clinical Outcomes	28 days	* Number of participants with a reduction in the time to extubation; * Number of participants with a reduction in ICU days; * Number of participants with a reduction in hospital days

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States