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

Aerogen

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04452669

APC-VPCOV-CLN-001

Details and patient eligibility

About

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 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Study Treatment

Experimental group

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.

Treatment:

Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)

Placebo Control

Placebo Comparator group

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.

Treatment:

Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)