A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 860
- 主要终点
- Time to alleviation of all primary influenza symptoms and fever
研究概览
简要总结
The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
详细描述
The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
- •Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: ≥ 38.0°C (≥ 100.4°F) if < 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
- •Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
- •Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication
排除标准
- •Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
- •Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
- •Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
- •Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
- •Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
- •Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
- •Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
- •Has an allergy or contraindication to use of acetaminophen (paracetamol)
- •Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the Investigator to be ineligible for any reason
- •Previously participated in a clinical trial of favipiravir (T-705)
- •Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
研究组 & 干预措施
favipiravir
干预措施: favipiravir (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to alleviation of all primary influenza symptoms and fever
时间窗: 21 days
Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be \< 38.0°C (\<100.4°F) for subjects \< 65 years old and \< 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature.
次要结局
- To characterize the PK of favipiravir when used under clinical conditions(21 days)
- Time to alleviation each of the primary influenza symptoms and fever(21 days)