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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04478071 | Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 448 | — | — | Aug 22, 2020 | Mar 25, 2022 | Mar 26, 2025 | 1 | United States |
National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities
| Arm | Type | Description |
|---|---|---|
| vadadustat | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| vadadustat | DRUG | Participants will receive vadadustat once daily for 14 days. |
| placebo | DRUG | Participants will receive matching placebo once daily for 14 days. |
Inclusion Criteria: * Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory * Admitted to the hospital within 36 hours * Oxygen saturation ...