Trial Outcomes & Findings for VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation (NCT NCT04452669)
NCT ID: NCT04452669
Last Updated: 2025-07-31
Results Overview
Number of participants that were extubated
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
10 days post-randomization
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Treatment
n=6 Participants
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.
|
Placebo Control
n=5 Participants
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
|
Age, Customized
>65 years
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 10 days post-randomizationPopulation: ITT Population
Number of participants that were extubated
Outcome measures
| Measure |
Study Treatment
n=6 Participants
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.
|
Placebo Control
n=5 Participants
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.
|
|---|---|---|
|
Change in Respiratory Failure
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 10 days post-randomizationPopulation: ITT Population
Number of participants that required ECMO or left ventricular assist device (LVAD)
Outcome measures
| Measure |
Study Treatment
n=6 Participants
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.
|
Placebo Control
n=6 Participants
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.
|
|---|---|---|
|
Change in Cardiac/Circulatory Failure
|
0 Participants
|
0 Participants
|
Adverse Events
Study Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Placebo Control
Serious events: 4 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Study Treatment
n=6 participants at risk
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.
|
Placebo Control
n=5 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening of ARDS
|
0.00%
0/6 • Adverse event data were collected from randomization through 28 days post-randomization.
|
20.0%
1/5 • Adverse event data were collected from randomization through 28 days post-randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of Acute Hypoxic Respiratory Failure
|
16.7%
1/6 • Adverse event data were collected from randomization through 28 days post-randomization.
|
60.0%
3/5 • Adverse event data were collected from randomization through 28 days post-randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic Respiratory Failure
|
0.00%
0/6 • Adverse event data were collected from randomization through 28 days post-randomization.
|
20.0%
1/5 • Adverse event data were collected from randomization through 28 days post-randomization.
|
Other adverse events
| Measure |
Study Treatment
n=6 participants at risk
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.
|
Placebo Control
n=5 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
0.00%
0/6 • Adverse event data were collected from randomization through 28 days post-randomization.
|
20.0%
1/5 • Adverse event data were collected from randomization through 28 days post-randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place