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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04551768 | Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 | PHASE1 | COMPLETED | 51 | — | — | Feb 10, 2021 | Aug 17, 2021 | Aug 26, 2021 | 4 | Greece, Mexico |
The severity rating will be based on the ordinal scale of clinical status as follows: 1. Death. 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, not requiring supplemental oxygen. 6. Not hospitalized, limitation on activities. 7. Not hospitalized, no limitations on activities.
| Arm | Type | Description |
|---|---|---|
| 50 mg/mL Virazole | EXPERIMENTAL | 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. |
| 100 mg/mL Virazole | EXPERIMENTAL | 100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. |
| Name | Type | Description |
|---|---|---|
| 50 mg/mL Virazole | DRUG | 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. |
| 100 mg/mL Virazole | DRUG | 100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. |
Inclusion Criteria: 1. Male or non-pregnant female ≥ 18 years of age. 2. Willing and able to provide written informed consent (or provided by a proxy). 3. Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection. 4. PaO2/FiO2 ratio \<300 mmHg. 5. Illness of any duration...