Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04527471 | Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 | PHASE2 | COMPLETED | 45 | — | — | Sep 4, 2020 | May 1, 2021 | Sep 22, 2022 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| Ensifentrine Dose 1 | DRUG | Study drug delivered twice daily via pMDI |
| Placebo pMDI | DRUG | Placebo delivered twice daily via pMDI |
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 ...