COVID-19Phase 2VPCOVIDNCT04452669

VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

A Phase 2 study testing VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) in people with COVID-19, run by Aerogen Pharma Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2020to 29 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

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

Read the 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.

Conditions: COVID-19
Being tested: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)
Keywords: COVID-19, ARDS
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)Drug
Also called inhaled Flolan
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.

Study groups in NCT04452669
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202029 Jun 2021

First posted30 Jun 2020
Study start15 Sep 2020
Primary completion29 Jun 2021
Study completion29 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04452669
Sponsor's protocol ID: APC-VPCOV-CLN-001
Acronym: VPCOVID
Status last verified: Jul 2025
First submitted: 29 Jun 2020
Last updated: 31 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04452669
Acronym / sponsor ID: VPCOVID / APC-VPCOV-CLN-001
Conditions: COVID-19
Keywords: COVID-19, ARDS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Aerogen Pharma LimitedIndustry (pharma, biotech, devices)
Collaborators: Ohio State University
Study start: 15 Sep 2020 (actual)
Primary completion: 29 Jun 2021 (actual)
Study completion: 29 Jun 2021 (actual)
First posted: 30 Jun 2020 (actual)
Results: Posted 31 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC

Arm	Type	Receives
Study Treatment	Experimental	Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
Placebo Control	Placebo comparator	Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)Also: inhaled FlolanVentaProst 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.	Drug	Placebo Control, Study Treatment

Primary outcome

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

Results and safety

Results posted to the registry on 31 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Treatment	6	5
Placebo Control	5	1

Primary outcome: Change in Respiratory Failure

Time frame: 10 days post-randomization. Count of participants. Unit: Participants

Measure	Study Treatment n = 6	Placebo Control n = 5
Value	3	2

Population analysed: ITT Population

Primary outcome: Change in Cardiac/Circulatory Failure

Time frame: 10 days post-randomization. Count of participants. Unit: Participants

Measure	Study Treatment n = 6	Placebo Control n = 6
Value	0	0

Population analysed: ITT Population

Adverse events

Time frame: Adverse event data were collected from randomization through 28 days post-randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Treatment	1 of 6 (16.7%)	0 of 6 (0%)	1 of 6
Placebo Control	4 of 5 (80%)	1 of 5 (20%)	4 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Veronica Franco, MD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) in people with COVID-19, run by Aerogen Pharma Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Respiratory Failure (time frame: 10 days post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04452669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.