Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Covid-19; SARS-CoV-2
• Intervention / Treatment: Drug: Ensifentrine Dose 1; Drug: Placebo pMDI

Detailed Description

Expploratory endpoint, pilot study, not statistically powered

go to protocol

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Recovery	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.	Day 29

Collaborators and Investigators

• Sponsor: Verona Pharma Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: RPL554-COV-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Verona Pharma will not be sharing individual deidentified participant data or other relevant study documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No