COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Time to Clearance of Viral Shedding
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
详细描述
Up to 60 hospitalized patients with laboratory confirmed influenza who provide informed consent and meet trial inclusion/exclusion criteria.
Experimental Design and Methods In a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial, hospitalized patients with laboratory confirmed influenza meeting inclusion and exclusion criteria, will be provided information on the trial, offered enrollment, and enrolled randomly in a 1:1 ratio to one of two groups upon signing of the study's informed consent form: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
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Group 1, the combination treatment group will receive oseltamivir and baloxavir
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Oseltamivir: 75 mg po bid for 5 days
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Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg
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Group 2, the standard treatment group will receive oseltamivir and placebo
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Oseltamivir: 75 mg po bid for 5 days
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Placebo: Once
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults >/= 18 years old
- •Laboratory confirmed influenza A and/or B (rapid test or PCR)
- •Able to be enrolled, randomized, and dosed with study drug within 8 hours of the decision to admit patient to hospital for treatment of influenza
- •Oseltamivir treatment ordered by clinical team AND patient is able to be enrolled:
- •Prior to the initial dose of oseltamivir OR
- •Within 60 minutes after the initial dose of oseltamivir
- •Subject or Legally Authorized Representative able to and willing to provide written informed consent
- •Able to commit to 30 days of follow up
- •Weight > 40 kg
- •SARS-CoV-2 PCR swab sent within 1 week of enrollment
排除标准
- •ESRD not undergoing hemodialysis (HD) or peritoneal dialysis (CAPD)
- •Severe hepatic insufficiency, cirrhosis, acute or chronic liver failure
- •Nausea/vomiting, aspiration risk, or other conditions precluding the ability to use oral medications (if patient is NPO including meds, otherwise unable to swallow oral medications)
- •Influenza medication use within the prior week, other than the initial oseltamivir given during this hospitalization for this episode of influenza
- •Oseltamivir or baloxavir allergy or intolerance
- •Pregnancy (need negative pregnancy test (urine or blood) in reproductive age women)
- •Absence of dependable contraception in reproductive age women
- •Inability to obtain informed consent
- •Refusal of oseltamivir therapy by patient as baseline treatment
研究组 & 干预措施
baloxavir
Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg
干预措施: Baloxavir (Drug)
placebo
placebo po once
干预措施: Placebos (Drug)
结局指标
主要结局
Time to Clearance of Viral Shedding
时间窗: 30 days
influenza viral titer obtained by nasal swab using qCulture
次要结局
未报告次要终点
研究者
Daniel Freilich, MD
attending physician - hospitalist
Bassett Healthcare