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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04447469 | Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation | PHASE2 | COMPLETED | 814 | — | — | Jul 28, 2020 | Jan 14, 2022 | Jan 22, 2025 | 32 | United States, Brazil +3 |
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
| Arm | Type | Description |
|---|---|---|
| 10 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 1) | PLACEBO_COMPARATOR | Non-mechanically ventilated participants administered placebo as a single IV infusion |
| 10 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 2) | PLACEBO_COMPARATOR | Mechanically ventilated participants administered placebo as a single IV infusion |
| Name | Type | Description |
|---|---|---|
| mavrilimumab | DRUG | anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G \[IgG4\]) |
| Placebo | OTHER | matching placebo |
Key Inclusion Criteria: * Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations. * Age of ≥ 18 years * Pos...