VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 positive by RT-PCR test Patients who require invasive mechanical ventilation. Consent or professional consent obtained 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Treatment<br>Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated. | Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)<br>* 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.<br>* Other names: inhaled Flolan;|
| Placebo Comparator: Placebo Control<br>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. | Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)<br>* 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.<br>* Other names: inhaled Flolan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Respiratory Failure | 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 | 10 days | 
| Reduction in Cardiac/Circulatory Failure | 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Oxygenation | Number of participants that demonstrate a change in FiO2 by 50% or more. | 10 days | 
| Improved Clinical Outcomes | 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 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, ARDS