Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Condition: Coronavirus Infection; Covid-19; SARS-CoV-2
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Ensifentrine Dose 1; Placebo pMDI
Intervention description: Study drug delivered twice daily via pMDI; Placebo delivered twice daily via pMDI
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.