VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation (VPCOVID)

July 9, 2025 updated by: Aerogen Pharma Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Treatment
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)
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 Names:
  • inhaled Flolan
Placebo Comparator: Placebo Control
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)
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 Names:
  • inhaled Flolan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Respiratory Failure
Time Frame: 10 days post-randomization
Number of participants that were extubated
10 days post-randomization
Change in Cardiac/Circulatory Failure
Time Frame: 10 days post-randomization
Number of participants that required ECMO or left ventricular assist device (LVAD)
10 days post-randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerogen Pharma Limited

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Veronica Franco, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APC-VPCOV-CLN-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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