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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04551768
Collaborator
(none)
51
Enrollment
4
Locations
2
Arms
6.2
Actual Duration (Months)
12.8
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: 50 mg/mL Virazole
  • Drug: 100 mg/mL Virazole
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
51 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
Actual Study Start Date :
Feb 10, 2021
Actual Primary Completion Date :
Aug 17, 2021
Actual Study Completion Date :
Aug 17, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment [7 days]

    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

  1. Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours. [7 days]

  2. Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours. [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch Health Site 201 Athens Attika Greece 10676
2 Bausch Health Site 203 Athens Attika Greece 11527
3 Bausch Health Site 204 Alexandroupoli Evros Greece 68100
4 Bausch Site 304 Tijuana Zona Rio Mexico 22320

Sponsors and Collaborators

  • Bausch Health Americas, Inc.

Investigators

  • Study Director: Anya Loncaric, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT04551768
Other Study ID Numbers:
  • BHC-RIB-5401-GL
First Posted:
Sep 16, 2020
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
COVID-19
Ribavirin

Study Results

No Results Posted as of Aug 26, 2021