Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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COVID19

Intervention / Treatment
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* Drug: 50 mg/mL Virazole
* Drug: 100 mg/mL Virazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female ≥ 18 years of age. Willing and able to provide written informed consent (or provided by a proxy). Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection. PaO2/FiO2 ratio <300 mmHg. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR 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: Pregnant or breast feeding. Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.). Presence of secondary bacterial pneumonia. Presence of significant pulmonary fibrosis. Hypotension (need for hemodynamic pressors to maintain blood pressure). Greater than 7 days on mechanical ventilation. Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender. History of COPD or bronchospasm prior to COVID-19 infection. History of hypersensitivity to ribavirin. Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study Subject is currently participating in any drug or device clinical investigation. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg/mL Virazole<br>50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. | Drug: 50 mg/mL Virazole<br>* 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.<br>|
| Experimental: 100 mg/mL Virazole<br>100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. | Drug: 100 mg/mL Virazole<br>* 100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |