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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
Completed
Phase
Phase 1
Locations
International
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

  • Bausch Health Site 201
  • Bausch Health Site 203
  • Bausch Health Site 204
  • Bausch Site 304

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
September 15, 2020
Last Updated
August 25, 2021
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04551768
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
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

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
51 (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
Facility Information:
Facility Name
Bausch Health Site 201
City
Athens
State/Province
Attika
ZIP/Postal Code
10676
Country
Greece
Facility Name
Bausch Health Site 203
City
Athens
State/Province
Attika
ZIP/Postal Code
11527
Country
Greece
Facility Name
Bausch Health Site 204
City
Alexandroupoli
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece
Facility Name
Bausch Site 304
City
Tijuana
State/Province
Zona Rio
ZIP/Postal Code
22320
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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