Trials / Completed
CompletedNCT04551768
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio \<300 mmHg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 50 mg/mL Virazole | 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. |
| DRUG | 100 mg/mL Virazole | 100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. |
Timeline
- Start date
- 2021-02-10
- Primary completion
- 2021-08-17
- Completion
- 2021-08-17
- First posted
- 2020-09-16
- Last updated
- 2021-08-26
Locations
4 sites across 2 countries: Greece, Mexico
Source: ClinicalTrials.gov record NCT04551768. Inclusion in this directory is not an endorsement.