- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356677
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
June 17, 2021 updated by: Bausch Health Americas, Inc.
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
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
Time Frame: 7 days
|
The severity rating will be based on the ordinal scale of clinical status as follows:
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
Time Frame: 7 days
|
7 days
|
Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 22, 2020
Study Record Updates
Last Update Posted (Actual)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- BHC-RIB-5401-HC
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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