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

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 Overview

• Status: Completed
• Conditions: COVID19
• Intervention / Treatment: Drug: 50 mg/mL Virazole; Drug: 100 mg/mL Virazole

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Greece
  • Attika
    • Athens, Attika, Greece, 10676
      • Bausch Health Site 201
    • Athens, Attika, Greece, 11527
      • Bausch Health Site 203
  • Evros
    • Alexandroupoli, Evros, Greece, 68100
      • Bausch Health Site 204
• Mexico
  • Zona Rio
    • Tijuana, Zona Rio, Mexico, 22320
      • Bausch Site 304

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant female ≥ 18 years of age.
2. Willing and able to provide written informed consent (or provided by a proxy).
3. Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
4. PaO2/FiO2 ratio <300 mmHg.

5. 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.
6. 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:

1. Pregnant or breast feeding.
2. Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
3. Presence of secondary bacterial pneumonia.
4. Presence of significant pulmonary fibrosis.
5. Hypotension (need for hemodynamic pressors to maintain blood pressure).
6. Greater than 7 days on mechanical ventilation.
7. Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender.
8. History of COPD or bronchospasm prior to COVID-19 infection.
9. History of hypersensitivity to ribavirin.
10. Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
11. Subject is currently participating in any drug or device clinical investigation.
12. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): August 17, 2021
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: BHC-RIB-5401-GL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No