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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06729593 | Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) | PHASE3 | COMPLETED | 87 | — | — | Apr 20, 2021 | Nov 20, 2022 | Oct 9, 2025 | 40 | United States |
The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.
| Arm | Type | Description |
|---|---|---|
| Remdesivir + SOC | EXPERIMENTAL | - |
| Placebo + SOC | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Remdesivir | BIOLOGICAL | Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. |
| Remdesivir Placebo | BIOLOGICAL | Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. |
| Corticosteroid | DRUG | In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
Inclusion Criteria: Refer to the master protocol (NCT04843761) Exclusion Criteria: Refer to the master protocol (NCT04843761) Additional Exclusion Criteria: * Prior receipt of any dose of remdesivir during the present illness * GFR (glomerular filtration rate) \< 30 ml/min and not receiving dia...