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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
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