VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-06-29

Brief Summary

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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.

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Detailed Description

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo controlled

Study Groups

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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.

Group Type EXPERIMENTAL

VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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inhaled Flolan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No