Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mL Virazole, mL Virazole · 1 trial · 1 indication
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...
mL Virazole is an investigational drug being studied for the treatment of hospitalized adult participants with respiratory distress due to COVID-19. It is being evaluated in a Phase 1 clinical trial to assess its safety and efficacy in this patient population.
mL Virazole is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC. The company is conducting clinical research to evaluate the drug's potential in treating COVID-19.
mL Virazole is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for COVID-19.
mL Virazole has one completed clinical trial, identified as NCT04551768. This Phase 1 study evaluated the safety and efficacy of VIRAZOLE in hospitalized adult participants with respiratory distress due to COVID-19, enrolling 51 participants in Greece and Mexico.
Yes, mL Virazole is also known as VIRAZOLE. The clinical trial NCT04551768 refers to the drug as VIRAZOLE, and it is being studied for the treatment of COVID-19 in hospitalized adults with respiratory distress.