Status:
WITHDRAWN
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19_#2
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04356677
Start Date
May 1 2021
End Date
August 1 2021
Last Update
September 16 2025
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