Print

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Placebo controlled

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • inhaled Flolan
Placebo Comparator
Placebo Control 		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)
    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 names:
    • inhaled Flolan

Recruiting Locations

More Details

NCT ID
NCT04452669
Status
Completed
Sponsor
Aerogen Pharma Limited

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.