Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 50 mg/mL Virazole 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. |
Drug: 50 mg/mL Virazole
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
|
| Experimental: 100 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
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
|
Outcome Measures
Primary Outcome Measures
- Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment [7 days]
The severity rating will be based on the ordinal scale of clinical status as follows: Death. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Not hospitalized, limitation on activities. Not hospitalized, no limitations on activities.
Secondary Outcome Measures
- Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours. [7 days]
- Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours. [7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or non-pregnant female ≥ 18 years of age.
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Willing and able to provide written informed consent (or provided by a proxy).
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Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
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PaO2/FiO2 ratio <300 mmHg.
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Illness of any duration, and at least one of the following:
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Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
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Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR
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Requiring mechanical ventilation and/or supplemental oxygen.
- Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months.
Exclusion Criteria:
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Pregnant or breast feeding.
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Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
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Presence of secondary bacterial pneumonia.
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Presence of significant pulmonary fibrosis.
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Hypotension (need for hemodynamic pressors to maintain blood pressure).
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Greater than 7 days on mechanical ventilation.
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Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender.
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History of COPD or bronchospasm prior to COVID-19 infection.
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History of hypersensitivity to ribavirin.
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Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
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Subject is currently participating in any drug or device clinical investigation.
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Subject has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Anya Loncaric, Bausch Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHC-RIB-5401-HC