VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

COVID-19 Clinical Trial

— VPCOVID  

Official title:

Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452669
• Other study ID #: APC-VPCOV-CLN-001
• Status: Completed
• Phase: Phase 2
• Start date: September 15, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: August 2021
• Source: Aerogen Pharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Aerogen Pharma Limited	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Respiratory Failure	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	10 days
Primary	Reduction in Cardiac/Circulatory Failure	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	10 days
Secondary	Improvement in Oxygenation	Number of participants that demonstrate a change in FiO2 by 50% or more.	10 days
Secondary	Improved Clinical Outcomes	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	28 days