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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04402060 | A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19 | PHASE1 | COMPLETED | 72 | — | — | May 28, 2020 | Feb 13, 2021 | Mar 23, 2022 | 24 | United States, Brazil |
TEAEs were defined as those adverse events that developed or worsened in severity after initiation of the first dose of study drug and up to 30 (+7) days beyond the last dose of study drug. A serious TEAE was any TEAE or suspected adverse reaction that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes: death; is life threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| 180 mg APL-9 IV plus SOC | EXPERIMENTAL | - |
| Isotonic saline plus SOC | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| APL-9 | DRUG | Complement (C3) Inhibitor |
| Vehicle Control | OTHER | Normal saline of equal volume to active arm |
Inclusion Criteria: * Be at least 18 years of age at time of informed consent * Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening * Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with P...