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Completed

NCT Number: NCT04452669

VentaProst 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

Drug

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

Primary outcomes

  1. Change in Respiratory Failure

    Time frame: 10 days post-randomization

    Number of participants that were extubated

  2. Change in Cardiac/Circulatory Failure

    Time frame: 10 days post-randomization

    Number of participants that required ECMO or left ventricular assist device (LVAD)

Sponsors and collaborators

Lead sponsor

Aerogen Pharma Limited

Industry

Collaborators

  • Ohio State University

Registry information

Official study 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

Acronym: VPCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2020
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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