Trial Outcomes & Findings for Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 (NCT NCT04527471)
NCT ID: NCT04527471
Last Updated: 2022-09-22
Results Overview
Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Day 29
Results posted on
2022-09-22
Participant Flow
45 patients hospitalized with COVID-19 enrolled and randomized.
45 patients randomized to receive either RPL554 2mg via pMDI BID or placebo via pMDI BID in addition to standard of care treatment for COVID-19 disease until discharged or Day 29, whichever was first.
Participant milestones
| Measure |
Ensifentrine + Standard of Care
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
15
|
|
Overall Study
Hospitalized up to 7 Days
|
24
|
12
|
|
Overall Study
Hospitalized for > 7 Days
|
6
|
3
|
|
Overall Study
COMPLETED
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ensifentrine + Standard of Care
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Ensifentrine + Standard of Care
n=30 Participants
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
n=15 Participants
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
15 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
COVID-19 Disease Severity (Moderate)
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Smoking Status (Previous)
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Supplemental Oxygen Use (Yes)
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
2 or more Co-Morbidities
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
145 mmHg
n=5 Participants
|
124 mmHg
n=7 Participants
|
138 mmHg
n=5 Participants
|
|
Smoking Status (Current)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
Outcome measures
| Measure |
Ensifentrine + Standard of Care
n=30 Participants
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
n=15 Participants
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
|---|---|---|
|
Proportion of Patients With Recovery
|
29 Participants
|
15 Participants
|
Adverse Events
Ensifentrine + Standard of Care
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Placebo + Standard of Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ensifentrine + Standard of Care
n=30 participants at risk
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
n=15 participants at risk
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
Other adverse events
| Measure |
Ensifentrine + Standard of Care
n=30 participants at risk
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Ensifentrine Dose 1: Study drug delivered twice daily via pMDI
|
Placebo + Standard of Care
n=15 participants at risk
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
Placebo pMDI: Placebo delivered twice daily via pMDI
|
|---|---|---|
|
Cardiac disorders
Sinus bradycardia and Atrioventricular block first degree
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/30 • Over 60 days
|
6.7%
1/15 • Over 60 days
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Over 60 days
|
6.7%
1/15 • Over 60 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Over 60 days
|
6.7%
1/15 • Over 60 days
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30 • Over 60 days
|
6.7%
1/15 • Over 60 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Over 60 days
|
0.00%
0/15 • Over 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place