VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

NCT04452669 | Completed Phase 2 Results FDA Drug

• 1 other identifier: APC-VPCOV-CLN-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; ARDS

Outcome Measures

Primary Outcomes (2)

• Change in Respiratory Failure

  Number of participants that were extubated

  10 days post-randomization

• Change in Cardiac/Circulatory Failure

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

  10 days post-randomization

Study Arms (2)

Study Treatment

EXPERIMENTAL

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)

Placebo Control

PLACEBO COMPARATOR

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)

Interventions

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.

Also known as: inhaled Flolan

Placebo Control; Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerogen Pharma Limited: lead
• Ohio State University: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: David Durand, MD
• Organization: Aerogen Pharma

ddurand@aerogenpharma.com

510-928-2111

Study Officials

• Veronica Franco, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: September 15, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Locations

US (1)