JPRN-jRCT2031230140招募中3 期
A Phase 3 study of S-217622 in pediatric participants aged 6 to <12 with SARS-CoV-2 infection
Gomez Juan Carlos0 个研究点目标入组 120 人开始时间: 2023年6月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- >= 6age old 至 < 12age old（—）
- 性别
- All
入选标准
- •Participant who was diagnosed as SARS-CoV-2 positive within 72 hours before randomization
- •-Participant who may be randomized within 72 hours after COVID-19 onset
- •-Participant who has at least one moderate or severe COVID-19 symptom at screening
- •-Participant with body weight of >= 20 kg at screening
排除标准
- •-Participant with SpO2 of <= 93% (room air)
- •-Participant requiring oxygen treatment
- •-Participant requiring mechanical ventilation
- •-Participant who is strongly suspected to have worsening of SARS-CoV-2 infection symptoms within 48 hours after randomization
- •-Participant who is suspected to have active systemic infection requiring treatment
- •-Participant who has or suspected to have MIS-C/PIMS
- •-Participant who is known to have renal impairment with CrCl of < 30 mL/min by the Schwartz formula or requiring dialysis
- •-Participant who has severe hepatic impairment
- •-Participant who has history of febrile seizure or epilepsy
研究者
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