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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05780281 | VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) | PHASE3 | COMPLETED | 367 | — | — | Dec 16, 2020 | Oct 4, 2022 | Dec 27, 2023 | 105 | United States, Denmark +6 |
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Ordinal outcome with 7 mutually exclusive categories
| Arm | Type | Description |
|---|---|---|
| VIR-7831 plus SOC | EXPERIMENTAL | * VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion |
| Placebo plus SOC | PLACEBO_COMPARATOR | * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion |
| Name | Type | Description |
|---|---|---|
| VIR-7831 | BIOLOGICAL | VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. |
| Placebo | BIOLOGICAL | Commercially available 0.9% sodium chloride solution |
| Remdesivir | BIOLOGICAL | Antiviral agent |
Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: 1. Pregnant women 2. Nursing mothers In addition, prior to the initial futility assessment which is performed when approximately 150 partic...