A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
研究概览
简要总结
To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
详细描述
This study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the efficacy and safety of different doses of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
Approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio of 1:1:1:1 to receive study treatment orally: "40 mg TG-1000", "80 mg TG-1000", "40mg+40mg TG-1000" or "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)
盲法说明
Quadruple
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent.
- •Age ≥ 18 (or legal adult age) to < 65 years at the time of signing the informed consent.
- •Must have a positive result of Rapid influenza diagnostic test (RIDT) or Polymerase chain reaction (PCR).
- •The time interval between the onset of symptoms and the randomization is 48 hours or less.
- •Must be able to comply with all study procedures and assessments, including completion of the patient diary.
排除标准
- •Patients with severe influenza virus infection requiring inpatient treatment.
- •Patients with high risk factors may develop into severe cases.
- •Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
- •Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
- •Purulent sputum or purulent tonsillitis.
- •Positive nucleic acid test for COVID-
- •Suspects allergic to active ingredients or excipients.
- •Body weight < 40 kg.
- •Has received anti-influenza drug.
- •Has received any investigational agents or devices for any indication within 30 days prior to Screening.
- •Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
研究组 & 干预措施
40 mg TG-1000
Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
干预措施: TG-1000 (Drug)
80 mg TG-1000
Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.
干预措施: TG-1000 (Drug)
40 mg TG-1000+40 mg TG-1000
Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of TG-1000 on Day 3.
干预措施: TG-1000 (Drug)
Placebo
Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
干预措施: TG-1000 (Drug)
结局指标
主要结局
The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
时间窗: Up to Day 9
The time between the initiation of the study treatment and the first time when the influenza virus RNA cannot be detected.
次要结局
- The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).(Up to Day 9)
- Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.(Up to Day 9)
- Time to return to preinfluenza health status.(Up to Day 9)
- The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).(Up to Day 9)
- The percentage of patients whose symptoms have been alleviated at each time point.(Up to Day 9)
- Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).(Up to Day 9)
- Time to alleviation of all influenza symptoms.(Up to Day 9)
- Body temperature at each time point.(Up to Day 9)
- The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire.(Up to Day 9)
- The percentage of patients taking acetaminophen.(Up to Day 9)
- The percentage of patients reporting normal temperature at each time point.(Up to Day 9)
- Time to resolution of fever.(Up to Day 9)