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

Primary Purpose

COVID19

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
50 mg/mL Virazole
100 mg/mL Virazole
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    50 mg/mL Virazole

    100 mg/mL Virazole

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
    Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.

    Full Information

    First Posted
    April 20, 2020
    Last Updated
    June 17, 2021
    Sponsor
    Bausch Health Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04356677
    Brief Title
    Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries.
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    50 mg/mL Virazole
    Arm Type
    Experimental
    Arm Description
    50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
    Arm Title
    100 mg/mL Virazole
    Arm Type
    Experimental
    Arm Description
    100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
    Intervention Type
    Drug
    Intervention Name(s)
    50 mg/mL Virazole
    Intervention Description
    50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
    Intervention Type
    Drug
    Intervention Name(s)
    100 mg/mL Virazole
    Intervention Description
    100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
    Primary Outcome Measure Information:
    Title
    Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
    Description
    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.
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
    Time Frame
    7 days
    Title
    Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anya Loncaric
    Organizational Affiliation
    Bausch Health
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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