COVID-19
Conditions
Keywords
COVID-19, ARDS
Brief 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.
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.
Interventions
DRUGVentaProst (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.
Sponsors
Ohio State University
Aerogen Pharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled
Intervention model description
Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Respiratory Failure | 10 days post-randomization | Number of participants that were extubated |
| Change in Cardiac/Circulatory Failure | 10 days post-randomization | Number of participants that required ECMO or left ventricular assist device (LVAD) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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.
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. | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 4 |
Baseline characteristics
| Characteristic | Study Treatment | Placebo Control | Total |
|---|---|---|---|
| Age, Customized <65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized >65 years | 3 Participants | 3 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 4 / 5 |
| other Total, other adverse events | 0 / 6 | 1 / 5 |
| serious Total, serious adverse events | 1 / 6 | 4 / 5 |
Outcome results
Primary
Change in Cardiac/Circulatory Failure
Number of participants that required ECMO or left ventricular assist device (LVAD)
Time frame: 10 days post-randomization
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Treatment | Change in Cardiac/Circulatory Failure | 0 Participants |
| Placebo Control | Change in Cardiac/Circulatory Failure | 0 Participants |
Primary
Change in Respiratory Failure
Number of participants that were extubated
Time frame: 10 days post-randomization
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Treatment | Change in Respiratory Failure | 3 Participants |
| Placebo Control | Change in Respiratory Failure | 2 Participants |