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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: COVID19

Treatments: Drug: 50 mg/mL Virazole; Drug: 100 mg/mL Virazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04551768

BHC-RIB-5401-GL

Details and patient eligibility

About

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).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

50 mg/mL Virazole

Experimental group

Description:

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

Treatment:

Drug: 50 mg/mL Virazole

100 mg/mL Virazole

Experimental group

Description:

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

Treatment:

Drug: 100 mg/mL Virazole