Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AR-301 (tosatoxumab)
AR-301 · 1 trial · 4 indications
Clinical cure rates of standard of care (SOC) alone and (SOC) with AR-301 at Day 21 as measured by all-cause mortality, need for mechanical ventilation and signs and symptoms of pneumonia.
Safety of AR-301 of treatment-emergent adverse events as assessed by changes assessed by the PI between treatment and placebo
Tolerability of AR-301 will be measured and evaluated by the severity of treatment-emergent adverse events using the CTCAE v 5.0.
| Arm | Type | Description |
|---|---|---|
| Study treatment | EXPERIMENTAL | Investigational/ Interventional Product group: AR-301 (tosatoxumab) 20 mg/kg administered once intravenously on the day of randomization. |
| Placebo treatment | PLACEBO_COMPARATOR | Control group: Placebo administered intravenously on the day of randomization. |
| Name | Type | Description |
|---|---|---|
| AR-301 | DRUG | AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment. |
| Placebo | OTHER | Placebo comparator |
Inclusion Criteria: 1. Written Informed Consent given by the patient or, if not possible, by a legally acceptable representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations. 2. To be at least 18 years o...
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