Coronavirus InfectionPhase 2NCT04527471
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
A Phase 2 study testing Ensifentrine Dose 1 in people with Coronavirus Infection and Covid-19, run by Verona Pharma Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Infection, Covid-19, SARS-CoV-2
- What is being tested?
- Ensifentrine Dose 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2020to 1 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the detailed description
Expploratory endpoint, pilot study, not statistically powered
go to protocol
- Conditions
- Coronavirus Infection, Covid-19, SARS-CoV-2
- Being tested
- Ensifentrine Dose 1, Placebo pMDI
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensifentrine Dose 1Drug
Study drug delivered twice daily via pMDI
Placebo pMDIDrug
Placebo delivered twice daily via pMDI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start4 Sep 2020
- Primary completion15 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verona Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527471
- Sponsor's protocol ID
- RPL554-COV-201
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Verona Pharma will not be sharing individual deidentified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04527471
- Acronym / sponsor ID
- RPL554-COV-201
- Conditions
- Coronavirus Infection, Covid-19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Verona Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensifentrine + Standard of Care | Active comparator | Drug: Ensifentrine Dose 130 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection |
| Placebo + Standard of Care | Placebo comparator | Drug: Placebo pMDI15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensifentrine Dose 1Study drug delivered twice daily via pMDI | Drug | Ensifentrine + Standard of Care |
| Placebo pMDIPlacebo delivered twice daily via pMDI | Drug | Placebo + Standard of Care |
Primary outcome
Proportion of Patients With Recovery
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Verona Pharma will not be sharing individual deidentified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensifentrine Dose 1 in people with Coronavirus Infection and Covid-19, run by Verona Pharma Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Recovery (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.