A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
研究概览
简要总结
Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.
详细描述
This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center study. Approximately 196 subjects with fever defined as body temperature >= 38˚C, with at least one respiratory symptom and one other constitutional symptom will be invited into this study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for influenza A and B will be conducted and only subjects with positive results could be recruited. All eligible subjects will be randomized to one of the following treatment group in a 1:1 ratio.
Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1 capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at enrollment. All flu symptom relief agents could be used only for rescue use of persistent fever or flu symptoms (>= 24 hours). A digital thermometer and diary card will be dispensed at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and daily record regarding the severity of their influenza symptoms and the level of interference on daily activity. The monitoring frequency will be twice daily (after drug administration) from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as remission of all flu symptoms and interferences). Treatment failure is defined as secondary illnesses, antibiotic use and hospitalization due to disease progression.
For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For subjects who are not completely cured before Day 15 (Visit 4), further therapy will be conducted and they should return on Day 29; for those who are completely cured, only a telephone follow-up will be conducted on Day 29.
The severity of fever will be scored using a 4-point scale:
0 = < 37.2°C
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control Group
Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal
干预措施: Placebo (Drug)
Study Group
Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
干预措施: Apomivir® (Drug)
结局指标
主要结局
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
时间窗: from day1 to day 29, the entire treatment period and follow-up period.
Safety endpoints: 1. Change in laboratory data 2. Adverse events 3. Serious adverse events (SAE)
To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
时间窗: from day 1 to day 29, depends on the time to sympton resolution of individual subjects.
The time to resolution of influenza symptom is defined as the duration from the study drug initiation to all flu symptom scores ≤ 1. Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
次要结局
- Level of interference on daily activity and time to alleviation of the interference during study period(twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured)
- Proportion of rescue medication used for fever or influenza symptoms during study period(twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured)
- Proportion and time to treatment failure during study period(from day 1 to day 29, including treatment period and follow-up period)
- Severity of influenza symptom score during study period(twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured)
- Change in virus titer.(Day 3, 6 compared to baseline (Day 1))
- Time to achieve afebrile(after initiation of study treatment)