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Ensifentrine Dose 1

Phase 2

Coronavirus Infection | Small molecule | Infectious Disease |Verona Pharma plc Sponsored ADR|Last Updated: Sep 22, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Ensifentrine Dose 1 · 1 trial · 3 indications

Phase 2 1
NCT04527471Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19Coronavirus Infection
COMPLETED45 Analytics
PHASE2COMPLETED
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Coronavirus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ensifentrine + Standard of CareACTIVE_COMPARATOR30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
Placebo + Standard of CarePLACEBO_COMPARATOR15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection

Interventions

NameTypeDescription
Ensifentrine Dose 1DRUGStudy drug delivered twice daily via pMDI
Placebo pMDIDRUGPlacebo delivered twice daily via pMDI
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Ensifentrine Dose 1

What is Ensifentrine Dose 1 used for?

Ensifentrine Dose 1 is an investigational small molecule being studied for the treatment of Coronavirus Infection, including COVID-19 and SARS-CoV-2. It is delivered via a pressurized metered-dose inhaler (pMDI) and is intended for hospitalized patients with COVID-19. The drug is currently in Phase 2 clinical development.

Who makes Ensifentrine Dose 1?

Ensifentrine Dose 1 is being developed by Verona Pharma plc Sponsored ADR, which trades under the ticker symbol VRNA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with coronavirus infection.

What phase is Ensifentrine Dose 1 in?

Ensifentrine Dose 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its effects in hospitalized patients with COVID-19.

What clinical trials is Ensifentrine Dose 1 in?

Ensifentrine Dose 1 has been studied in one completed Phase 2 clinical trial with the identifier NCT04527471. This trial was a randomized, double-blind, placebo-controlled pilot study that enrolled 45 participants in the United States. The study evaluated Ensifentrine or placebo delivered via pMDI in hospitalized patients with COVID-19.

Is Ensifentrine Dose 1 the same as Ensifentrine?

Ensifentrine Dose 1 refers to a specific dose of the drug Ensifentrine. The clinical trial NCT04527471 investigated this dose in patients with COVID-19. Ensifentrine is a small molecule being developed by Verona Pharma for respiratory conditions, and this particular dose is being evaluated for coronavirus infection.