jRCT2031230124进行中（未招募）不适用
A Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of S-217622 in the prevention of symptomatic SARS-CoV-2 infection in household contacts of an individual with symptomatic COVID-19 (SCORPIO-PEP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,600
- 主要终点
- Proportion of participants in the mITT population with a negative screening SARS-CoV-2 infection who are infected with SARS-CoV-2 and have COVID-19 symptoms onset through Day 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant who has a negative screening SARS-CoV-2 infection, as determined by SARS-CoV-2 test from any respiratory tract specimen at the local laboratory
- •Participant who has lived in household with SARS-CoV-2-infected patient and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study
- •Participant who is not considered by the investigator or subinvestigator to have SARS-CoV-2 infection, have no measured fever, and have no COVID-19 symptoms at Screening
- •Participant who can be randomized less than 72 hours from onset of COVID-19 symptoms in SARS-CoV-2-infected patient
排除标准
- •Participant in whom respiratory infection (eg, flu virus infection) other than COVID-19 was documented within 14 days prior to the Screening Visit
- •Participant who tested positive for SARS-CoV-2 in the past 6 months
- •Participant who received approved, authorized, or investigational anti-SARS-CoV-2 mAbs in the last 3 months
- •Participant who received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study
- •Participant who has a positive urine pregnancy test at Screening Visit or are lactating
结局指标
主要结局
Proportion of participants in the mITT population with a negative screening SARS-CoV-2 infection who are infected with SARS-CoV-2 and have COVID-19 symptoms onset through Day 10
时间窗: Day 10
Proportion of participants in the mITT population with a negative screening SARS-CoV-2 infection (central laboratory-confirmed negative RT-PCR test) who are infected with SARS-CoV-2 (central laboratory-confirmed positive RT-PCR test) and have COVID-19 symptoms onset through Day 10
次要结局
未报告次要终点
研究者
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