A Phase 3 study of S-217622 in pediatric participants aged 6 to <12 with SARS-CoV-2 infection

Shionogi & Co., Ltd.0 个研究点目标入组 120 人开始时间: 2023年6月29日最近更新: 2024年11月20日

试验速览

暂无简介。

•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

•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

-Adverse events, laboratory tests, vital signs -Plasma concentration of S-217622

未报告次要终点

发起方