Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19_#2

NCT ID: NCT04356677

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2021-08-31

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).

Conditions

COVID19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 mg/mL Virazole

50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.

Group Type: EXPERIMENTAL

50 mg/mL Virazole

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

100 mg/mL Virazole

Intervention Type: DRUG

100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.

Interventions

50 mg/mL Virazole

50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.

Intervention Type: DRUG

100 mg/mL Virazole

100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health

Other Identifiers

BHC-RIB-5401-HC

Identifier Type: -

Identifier Source: org_study_id