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
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.

Completed
COVID-19

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.
Other Name: inhaled Flolan

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Ohio State University
Columbus, Ohio, United States

Veronica Franco, MD, Principal Investigator
Ohio State University

Ohio State University
NCT Number
Keywords
Covid-19
ARDS
MeSH Terms
COVID-19
Epoprostenol
Tezosentan