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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04345614 | A Study of Auxora in Patients With Severe COVID-19 Pneumonia | PHASE2 | COMPLETED | 314 | — | — | Apr 8, 2020 | Jul 30, 2021 | Mar 30, 2026 | 17 | United States |
Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.
| Arm | Type | Description |
|---|---|---|
| Auxora (Part 1) | EXPERIMENTAL | Patients were randomized 1:1 to receive either Auxora or standard of care |
| Standard of Care (Part 1) | OTHER | Patients were randomized 1:1 to receive either Auxora or standard of care |
| Auxora (Part 2) | EXPERIMENTAL | Patients were randomized 1:1 to receive Auxora or Placebo |
| Placebo (Part 2) | PLACEBO_COMPARATOR | Patients were randomized 1:1 to receive Auxora or Placebo |
| Name | Type | Description |
|---|---|---|
| Auxora (Part 1) | DRUG | Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. |
| Standard of Care (Part 1) | DRUG | Patients received standard of care |
| Auxora (Part 2) | DRUG | Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. |
| Placebo (Part 2) | DRUG | Placebo will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Placebo will be administered intravenously (IV) over 4 hours. |
Part 1: Inclusion Criteria 1. 1\. The diagnosis of COVID-19 established standard RT-PCR assay; 2. At least 1 of the following symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. At least 1 of the followin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | — | Receipt of PCV20 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | — | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | NA | Undisclosed |
| Co-Diagnostics, Inc. | CODX | 1 | — | Undisclosed |