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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
50 mg/mL Virazole
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
干预措施: 50 mg/mL Virazole (Drug)
100 mg/mL Virazole
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
干预措施: 100 mg/mL Virazole (Drug)
结局指标
主要结局
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
时间窗: 7 days
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.
次要结局
- 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)