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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04351243 | A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE) | PHASE2 | COMPLETED | 227 | — | — | Apr 15, 2020 | Apr 1, 2021 | Dec 14, 2021 | 33 | United States |
"Incidence" is defined as the percent of subjects that died by Day 43
| Arm | Type | Description |
|---|---|---|
| Gimsilumab | EXPERIMENTAL | Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 |
| Placebo | PLACEBO_COMPARATOR | Normal saline on Day 1 Normal saline on Day 8 |
| Name | Type | Description |
|---|---|---|
| Gimsilumab | DRUG | Gimsilumab is a fully human monoclonal antibody (mAb). |
| Placebo | DRUG | Normal saline |
Inclusion Criteria: 1. Male or non-pregnant female age ≥18 years, inclusive 2. Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form 3. Has laboratory-conf...