Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Canakinumab · 1 trial · 2 indications
Number of patients with either an improvement of two points on a seven category ordinal scale or discharge from the hospital
| Arm | Type | Description |
|---|---|---|
| High Dose Intervention | ACTIVE_COMPARATOR | 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) |
| Low Dose Intervention | ACTIVE_COMPARATOR | 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) |
| Control | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Canakinumab Injection 600mg | DRUG | Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours |
| Canakinumab Injection 300mg | DRUG | Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours |
| Placebos | DRUG | 250 mL of 5% dextrose infused IV over 2 hours |
Inclusion Criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Hospitalized due to COVID-19 infection 3. Documented SARS-CoV2 acute myocardial injury: Defined as upper resp...