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

COVID19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551768
• Other study ID #: BHC-RIB-5401-GL
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2021
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2021
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID19

Intervention

Drug:
• 50 mg/mL Virazole
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
• 100 mg/mL Virazole
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.

Locations

Country	Name	City	State
Greece	Bausch Health Site 204	Alexandroupoli	Evros
Greece	Bausch Health Site 201	Athens	Attika
Greece	Bausch Health Site 203	Athens	Attika
Mexico	Bausch Site 304	Tijuana	Zona Rio

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

Greece,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	Time to recover gas exchange to a PaO2/FiO2 =300 for at least 24 hours.		7 days
Secondary	Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.		7 days