Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452669
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Aerogen Pharma Limited

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) Phase 2

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 an open label study of VentaProst in 10 confirmed COVID-19 patients compared to 20 COVID-19 historical control patients to assess the efficacy and safety of VentaProst given over 10 days at varying doses.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label study comparing study treatment group to historical controls who received SOC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


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 Name: inhaled Flolan




Primary Outcome Measures :
  1. Reduction in Respiratory Failure [ Time Frame: 10 days ]
    • 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

  2. Reduction in Cardiac/Circulatory Failure [ Time Frame: 10 days ]
    • 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 :
  1. Improvement in Oxygenation [ Time Frame: 10 days ]
    Number of participants that demonstrate a change in FiO2 by 50% or more.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452669


Contacts
Layout table for location contacts
Contact: Judy R Doto, RN, BSN 4847165438 judydoto@aerogenpharma.com

Locations
Layout table for location information
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Contact: Joe Santiago, BS, RRT       Joseph.santiago@osumc.edu   
Sponsors and Collaborators
Aerogen Pharma Limited
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Veronica Franco, MD Ohio State University
Layout table for additonal information
Responsible Party: Aerogen Pharma Limited
ClinicalTrials.gov Identifier: NCT04452669    
Other Study ID Numbers: APC-VPCOV-CLN-001
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aerogen Pharma Limited:
COVID-19
ARDS
Additional relevant MeSH terms:
Layout table for MeSH terms
Epoprostenol
Tezosentan
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents