VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2020

Detailed Description

This study will evaluate the potential therapeutic benefit of VentaProst in treating patients with COVID-19 at risk for the progression of 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.

Interventions

  • Drug: VentaProst (inhaled Flolan 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.

Arms, Groups and Cohorts

  • Experimental: Study Treatment
    • Up to 10 days of inhaled Flolan delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated.

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in Respiratory Failure
    • Time Frame: 10 days
    • Failure is defined by any one of the following: Requires VV ECMO Inability to extubate patient within 10 days or reintubation within < 24 hours Change in S/F, oxygenation index and P/F ratio ( greater than 15%) from baseline to 12 hours, Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and Day 10 (or end of treatment)
  • Reduction in cardiac/circulatory Failure
    • Time Frame: 10 days
    • Failure is defined by any one of the following: Need to begin inotropic or 10% increase in current vasopressor therapy Worsening hemodynamic parameters Cardiac troponin > 20% from baseline BNP greater than 15% of baseline Need for temporary mechanical circulatory support (IABP, Impella) Requires VA ECMO

Secondary Measures

  • Improvement in Oxygenation
    • Time Frame: 10 days
    • Improvement is defined as one of the following: • Stabilization of PaO2/FIO2 >250 • Improvement in FIO2 by 50% or improvements >15% in S/F, P/F ratio from baseline at 12 hours, Day 5 and Day 10 (or end of treatment)
  • Improvement in Clinical Outcomes
    • Time Frame: 28 Days
    • Improvement is defined as one of the following: • Shorter time to extubation following the site’s extubation protocol Free from reintubation Reduction in ICU days Reduction in the number of re-admissions to the ICU due to COVID-19 within 28 days. Reduction in hospital days Mortality (28 Days) defined as Cardiopulmonary mortality or mortality from all causes.

Participating in This Clinical Trial

Inclusion Criteria

1. Women and Men Age ≥18 years old (no upper limit)

2. Confirmed COVID-19 positive by RT-PCR test

3. Patients who require invasive mechanical ventilation.

4. Enrolled into study within 24 hours of being placed on mechanical ventilation

5. Consent or professional consent obtained

6. Duration of shortness of breath must be within the previous 14 days.

7. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).

8. Willing and able to comply with treatment schedule and follow-up.

Exclusion Criteria

1. Patients on ECMO support.

2. Patients receiving another inhalation research medication or inhaled nitric oxide.

3. Not expected to survive for 48 hours.

4. Pregnant (positive pregnancy test in a pre-dose examination) or breastfeeding

5. Open tracheostomy.

6. Clinical contra-indication, as deemed by the attending physician.

7. Allergy to Epoprostenol and its diluent

8. Using inhaled vasodilators at baseline.

9. Patients who are hemodynamically unstable as determined by investigator

10. Patients with significant hemoptysis as determined by investigator

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aerogen Pharma Limited
  • Collaborator
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Veronica Franco, MD, Principal Investigator, Ohio State University
  • Overall Contact(s)
    • Judy R Doto, RN, BSN, 4847165438, judydoto@aerogenpharma.com

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