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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04843761 | ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 | PHASE3 | COMPLETED | 473 | — | — | Apr 20, 2021 | Nov 20, 2022 | Oct 24, 2025 | 40 | United States |
The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \[Aviptadil\]: NCT06729606; H2 \[Remdesivir\]: NCT06729593).
| Arm | Type | Description |
|---|---|---|
| Stratum 1 - Aviptadil + Remdesivir + SOC | EXPERIMENTAL | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) |
| Stratum 1 - Aviptadil + Remdesivir Placebo + SOC | EXPERIMENTAL | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) |
| Stratum 1 - Aviptadil Placebo + Remdesivir + SOC | EXPERIMENTAL | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) |
| Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC | PLACEBO_COMPARATOR | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) |
| Stratum 2 - Aviptadil + SOC | EXPERIMENTAL | Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) |
| Stratum 2 - Aviptadil Placebo + SOC | PLACEBO_COMPARATOR | Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) |
| Stratum 3 - Remdesivir + SOC | EXPERIMENTAL | Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593) |
| Stratum 3 - Remdesivir Placebo + SOC | PLACEBO_COMPARATOR | Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593) |
| Stratum 4 - Aviptadil + SOC | EXPERIMENTAL | Eligible for Aviptadil and prior/current use of Remdesivir Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) |
| Stratum 4 - Aviptadil Placebo + SOC | PLACEBO_COMPARATOR | Eligible for Aviptadil and prior/current use of Remdesivir Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) |
| 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 | DRUG | Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. |
| Aviptadil | BIOLOGICAL | Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. |
| Aviptadil Placebo | DRUG | Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. |
| Corticosteroid | DRUG | In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. |
Inclusion Criteria: * Signed informed consent. * Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19 (not for purely public health or quarantine purposes). * Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilat...