A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2 in China
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Efficacy-Incidence of SARS-CoV-2 infection in 8 days
研究概览
简要总结
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 in China
详细描述
A multicentre, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals.Approximately 300 adults with household contact exposure to individuals with a confirmed SARS-CoV-2 infection will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •1、18-65 years old at the signing of informed consent. 2、Household contacts of individual with symptomatic COVID-
- •Symptomatic COVID-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or RT-PCR) positive for SARS-CoV-2 and must fulfill the following criteria 1) collection of the first positive SARS-CoV-2 test sample less than 24 hours before randomization, 2) have at least one symptom attributable to COVID-
- •3、RT-PCR test negative (with nasopharyngeal [NP] swab samples) OR rapid antigen test negative at the time of screening and without any suspicious COVID-19 symptoms within 2 weeks before randomization.
- •4、Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.
排除标准
- •Subject with a history of SARS-CoV-2 vaccinations within 1 months before randomization.
- •Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
- •With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
- •Allergic to the investigational agent or any components of the formulation. Pregnant or breast-feeding women.
- •Women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; Sexually active men who are unwilling to use medically acceptable birth control during the study period.
- •Have other conditions not suitable for inclusion as judged by the investigator.
研究组 & 干预措施
A：Azvudine 5 mg
Azvudine 5 mg, QD PO, D1-D7
干预措施: Azvudine (Drug)
B：Azvudine 3 mg
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
干预措施: Azvudine (Drug)
B：Azvudine 3 mg
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
干预措施: Placebo (Drug)
C：placebo
placebo 5 mg, QD PO, D1-D7
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy-Incidence of SARS-CoV-2 infection in 8 days
时间窗: Day 2 to Day 7
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 8 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
次要结局
未报告次要终点