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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04412057 | Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury | PHASE2 | COMPLETED | 88 | — | — | Jul 17, 2020 | Jan 19, 2021 | Mar 24, 2022 | 11 | United States |
Respiratory failure defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation, * Extracorporeal membrane oxygenation
| Arm | Type | Description |
|---|---|---|
| CERC-002 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CERC-002 | DRUG | Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. |
| Placebo | DRUG | Administered once subcutaneously |
Inclusion Criteria: 1. Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study. 2. Subject is ≥18 years of age at the time of informed consent and assent (as applicable). 3. Subject is male o...