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

NCT04551768 | Completed Phase 1

• 1 other identifier: BHC-RIB-5401-GL
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  7 days

Secondary Outcomes (2)

• Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.

  7 days

• Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.

  7 days

Study Arms (2)

50 mg/mL Virazole

EXPERIMENTAL

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

Drug: 50 mg/mL Virazole

100 mg/mL Virazole

EXPERIMENTAL

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

Drug: 100 mg/mL Virazole

Interventions

50 mg/mL Virazole DRUG

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

50 mg/mL Virazole

100 mg/mL Virazole DRUG

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

100 mg/mL Virazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female ≥ 18 years of age.
• Willing and able to provide written informed consent (or provided by a proxy).
• Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
• PaO2/FiO2 ratio \<300 mmHg.
• 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.
• Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months.

You may not qualify if:

• Pregnant or breast feeding.
• Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
• Presence of secondary bacterial pneumonia.
• Presence of significant pulmonary fibrosis.
• Hypotension (need for hemodynamic pressors to maintain blood pressure).
• Greater than 7 days on mechanical ventilation.
• Anemia defined as hemoglobin or RBC \<75% of the institutional lower limit of normal for race, age and gender.
• History of COPD or bronchospasm prior to COVID-19 infection.
• History of hypersensitivity to ribavirin.
• Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
• Subject is currently participating in any drug or device clinical investigation.
• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (4)

Bausch Health Site 201

Athens, Attica, 10676, Greece

Location

Bausch Health Site 203

Athens, Attica, 11527, Greece

Location

Bausch Health Site 204

Alexandroupoli, Evros, 68100, Greece

Location

Bausch Site 304

Tijuana, Zona Rio, 22320, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Anya Loncaric

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 16, 2020
• Study Start: February 10, 2021
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

ME (1); GR (3)