A Phase 1 interventional study of 50 mg/mL Virazole and 100 mg/mL Virazole in COVID19, sponsored by Bausch Health Americas, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Bausch Health Americas, Inc. · Phase 1, Interventional, and Treatment
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 51 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Illness of any duration, and at least one of the following:
Exclusion Criteria:
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
Drug: 50 mg/mL Virazole
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
Drug: 100 mg/mL Virazole
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
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.
Time frame: 7 days
Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
Time frame: 7 days
Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.