NCT01146535已完成2 期
Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Resolution of fever and flu symptoms
研究概览
简要总结
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fever >=38C
- •one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of < 48 hours' duration
- •body weight > 40 kg
- •positive for influenza A (nasal swab rapid test)
排除标准
- •pregnancy/lactation
- •history of depression or psychiatric disorders
- •history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
- •use of immunosuppressive therapy
- •HIV infection
研究组 & 干预措施
maltose
Placebo Comparator
maltose
200 mg maltose lozenges bid for 5 days
干预措施: maltose (Other)
Interferon-alpha
Experimental
Interferon-alpha
150 IU lozenges bid for 5 days
干预措施: Interferon-alpha (Drug)
Interferon-alpha
Experimental
Interferon-alpha
150 IU lozenges bid for 5 days
干预措施: Oseltamivir (Drug)
maltose
Placebo Comparator
maltose
200 mg maltose lozenges bid for 5 days
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Resolution of fever and flu symptoms
时间窗: Days 1-5
Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR).
次要结局
- Clinical response(Day 3 and Day 6)
- Proportion of poor responders(Day 3 and Day 6)
- Time to resolution of fever(Days 1-5)
- Time to resolution of influenza illness(Days 1-5)
- Symptom improvement(Days 1-5)
- OTC medication usage(Days 1-5)
- Physician visits(Days 6-10)
- Treatment failure(Days 1-28)
研究者
研究点 (4)
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