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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551768
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date August 26, 2021
Actual Study Start Date  ICMJE February 10, 2021
Actual Primary Completion Date August 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment [ Time Frame: 7 days ]
The severity rating will be based on the ordinal scale of clinical status as follows:
  1. Death.
  2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
  3. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
  4. Hospitalized, requiring supplemental oxygen.
  5. Hospitalized, not requiring supplemental oxygen.
  6. Not hospitalized, limitation on activities.
  7. Not hospitalized, no limitations on activities.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours. [ Time Frame: 7 days ]
  • Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours. [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID19
Intervention  ICMJE
  • Drug: 50 mg/mL Virazole
    50 mg/mL Virazole aerosolized and administered over 1 hour 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.
Study Arms  ICMJE
  • Experimental: 50 mg/mL Virazole
    50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
    Intervention: Drug: 50 mg/mL Virazole
  • Experimental: 100 mg/mL Virazole
    100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
    Intervention: Drug: 100 mg/mL Virazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2021)
51
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
50
Actual Study Completion Date  ICMJE August 17, 2021
Actual Primary Completion Date August 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece,   Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551768
Other Study ID Numbers  ICMJE BHC-RIB-5401-GL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anya Loncaric Bausch Health
PRS Account Bausch Health Americas, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP