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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356677
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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).

Condition or disease Intervention/treatment Phase
COVID19 Drug: 50 mg/mL Virazole Drug: 100 mg/mL Virazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours. [ Time Frame: 7 days ]
  2. Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours. [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356677


Contacts
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Contact: Alexandre Brkovic 1 514-904-4863 Alexandre.Brkovic@bauschhealth.com

Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Bausch Health
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT04356677    
Other Study ID Numbers: BHC-RIB-5401-HC
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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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
Additional relevant MeSH terms:
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Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents