Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Study Details
Study Description
Brief Summary
This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ensifentrine + Standard of Care 30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection |
Drug: Ensifentrine Dose 1
Study drug delivered twice daily via pMDI
|
| Placebo Comparator: Placebo + Standard of Care 15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection |
Drug: Placebo pMDI
Placebo delivered twice daily via pMDI
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with recovery [Day 29]
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.
Secondary Outcome Measures
- Time to recovery [Day 1 to Day 29]
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.
- Proportion of patients with recovery [Day 60]
- Proportion of patients with improvement (from Day 1) of one category using the 7-point ordinal scale [Days 7, 14 and 29]
- Proportion of patients with improvement (from Day 1) of two categories using the 7-point ordinal scale [Days 7, 14 and 29]
- Mortality rate [Days 29 and 60]
All-cause mortality
- Proportion of patients alive and not in respiratory failure [Day 29]
respiratory failure = requiring invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]
- Proportion of patients needing re-hospitalization [Day 60]
- Duration of hospitalization from Day 1 [Day 1 to Day 29]
- Mean change from baseline in 7-point ordinal scale [Days 7, 14 and 29]
- Total time on supplemental oxygen [Day 1 to Day 29]
- Incidence of new non-invasive ventilation or high flow oxygen use [Day 1 to Day 29]
- Duration of new non-invasive ventilation or high flow oxygen use [Day 1 to Day 29]
- Incidence of new oxygen use [Day 1 to Day 29]
- Duration of new oxygen use [Day 1 to Day 29]
- Incidence of new mechanical ventilator use [Day 1 to Day 29]
- Duration of new mechanical ventilator use [Day 1 to Day 29]
- Proportion of patients receiving invasive mechanical ventilation or ECMO [Days 7, 14 and 29]
Other Outcome Measures
- Incidence of Adverse Events (AEs) [Day 60]
- Respiration Rate [Day 1 to Day 29]
breaths/minute
- Heart Rate [Day 1 to Day 29]
beats/minute
- Body Temperature [Day 1 to Day 29]
- Blood Pressure [Day 1 to Day 29]
mmHg
- Level of Consciousness [Day 1 to Day 29]
AVPU scale
- Oxygen saturation [Day 1 to Day 29]
SpO2 %
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
-
Patient must be at least 18 years of age and less than or equal to 80 years of age at the time of informed consent.
-
Males are eligible to participate or females of non-childbearing potential or WOCBP who have a negative pregnancy test at screening are eligible to participate. WOCBP and female partners of male participants agree to either abstinence or use at least one primary form of highly effective contraception not including hormonal contraception from the time of screening through Day 60 following the first dose of study medication.
-
Clinical status consistent with 3, 4 or 5 on the Ordinal scale: Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring any supplemental oxygen; Hospitalized, requiring non-invasive ventilation or use of high flow oxygen devices.
-
Admission to hospital AND have a confirmed diagnosis of severe acute respiratory syndrome coronavirus (SARS-COV-2) infection confirmed by polymerase chain reaction (PCR) test AND displays at least one of the following: Respiratory rate > 24 breaths per minute; new cough; new atypical chest pain; new dyspnea; oxygen saturation < 97% at rest; chest x-ray with new changes consistent with COVID-related airspace disease.
-
Capable of complying with all study restrictions and procedures including ability to use the pMDI correctly.
Exclusion Criteria:
-
Participation in any other clinical trial of an experimental treatment for COVID-19, unless related to an expanded access program as part of Standard of Care at screening or during study.
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Evidence of multiorgan failure.
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Requiring mechanical ventilation at screening.
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Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) at screening.
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Creatinine clearance < 30 mL/min at screening.
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Pregnancy or lactation at screening.
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Allergy or other contraindication or one of ensifentrine.
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In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
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Use of prohibited medications (theophylline, PDE4 inhibitors [e.g. roflumilast, apremilast, crisaborole] within 48 hours of screening or during study)
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Any other reason that the Investigator considers makes the patient unsuitable to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- Verona Pharma Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RPL554-COV-201