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

NCT04527471 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RPL554-COV-201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Covid-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ensifentrine + Standard of Care

ACTIVE COMPARATOR

30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection

Drug: Ensifentrine Dose 1

Placebo + Standard of Care

PLACEBO COMPARATOR

15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection

Drug: Placebo pMDI

Interventions

Ensifentrine Dose 1 DRUG

Study drug delivered twice daily via pMDI

Ensifentrine + Standard of Care

Placebo pMDI DRUG

Placebo delivered twice daily via pMDI

Placebo + Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verona Pharma Inc: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This was an un-powered pilot study of ensifentrine pMDI in patients hospitalized for moderate COVID-19 infection.

Results Point of Contact

• Title: Margot MacDonald-berko
• Organization: Verona Pharma

margot.macdonald-berko@veronapharma.com

833-417-0262

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 26, 2020
• Study Start: September 4, 2020
• Primary Completion: February 15, 2021
• Study Completion: May 1, 2021
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)