NCT04527471

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Verona Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Expploratory endpoint, pilot study, not statistically powered go to protocol

Conditions

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

Interventions

Type	Name	Description
DRUG	Ensifentrine Dose 1	Study drug delivered twice daily via pMDI
DRUG	Placebo pMDI	Placebo delivered twice daily via pMDI

Timeline

• Start date: 2020-09-04
• Primary completion: 2021-02-15
• Completion: 2021-05-01
• First posted: 2020-08-26
• Last updated: 2022-09-22
• Results posted: 2022-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study