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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)
Sponsored by
Aerogen Pharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Treatment

Placebo Control

Arm Description

Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.

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.

Outcomes

Primary Outcome Measures

Reduction in Respiratory Failure
Number of participants that require ECMO Number of participants that cannot be extubated within 10 days or A downward change in Oxygenation Index by >15% from baseline
Reduction in Cardiac/Circulatory Failure
Number of participants that require ECMO Number of participants requiring inotropic therapy Number of participants that require mechanical circulatory support A change in Cardiac Troponin >20% from baseline or A change in BNP >15% from baseline

Secondary Outcome Measures

Improvement in Oxygenation
Number of participants that demonstrate a change in FiO2 by 50% or more.
Improved Clinical Outcomes
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

Full Information

First Posted
June 29, 2020
Last Updated
August 4, 2021
Sponsor
Aerogen Pharma Limited
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04452669
Brief Title
VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation
Acronym
VPCOVID
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerogen Pharma Limited
Collaborators
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo controlled
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Treatment
Arm Type
Experimental
Arm Description
Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)
Other Intervention Name(s)
inhaled Flolan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Respiratory Failure
Description
Number of participants that require ECMO Number of participants that cannot be extubated within 10 days or A downward change in Oxygenation Index by >15% from baseline
Time Frame
10 days
Title
Reduction in Cardiac/Circulatory Failure
Description
Number of participants that require ECMO Number of participants requiring inotropic therapy Number of participants that require mechanical circulatory support A change in Cardiac Troponin >20% from baseline or A change in BNP >15% from baseline
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Improvement in Oxygenation
Description
Number of participants that demonstrate a change in FiO2 by 50% or more.
Time Frame
10 days
Title
Improved Clinical Outcomes
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Franco, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

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