Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04527471|
Recruitment Status : Completed
First Posted : August 26, 2020
Results First Posted : September 22, 2022
Last Update Posted : September 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection Covid-19 SARS-CoV-2||Drug: Ensifentrine Dose 1 Drug: Placebo pMDI||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Single-center, Pilot, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ensifentrine in the Recovery of Hospitalized Patients With COVID-19|
|Actual Study Start Date :||September 4, 2020|
|Actual Primary Completion Date :||February 15, 2021|
|Actual Study Completion Date :||May 1, 2021|
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
- Proportion of Patients With Recovery [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- Evidence of multiorgan failure.
- Requiring mechanical ventilation at screening.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) at screening.
- Creatinine clearance < 30 mL/min at screening.
- Pregnancy or lactation at screening.
- Allergy or other contraindication or one of ensifentrine.
- 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.
- Use of prohibited medications (theophylline, PDE4 inhibitors [e.g. roflumilast, apremilast, crisaborole] within 48 hours of screening or during study)
- Any other reason that the Investigator considers makes the patient unsuitable to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527471
|United States, Alabama|
|The University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
Documents provided by Verona Pharma plc ( Verona Pharma Inc ):
|Responsible Party:||Verona Pharma Inc|
|Other Study ID Numbers:||
|First Posted:||August 26, 2020 Key Record Dates|
|Results First Posted:||September 22, 2022|
|Last Update Posted:||September 22, 2022|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Verona Pharma will not be sharing individual deidentified participant data or other relevant study documents.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases