JPRN-jRCT2031230124招募中3 期
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
Gomez Juan Carlos0 个研究点目标入组 2,200 人开始时间: 2023年6月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 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
研究者
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