臨床研究等提出・公開システム

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

A Phase 3 study of S-217622 in pediatric participants

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

June. 16, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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

Both

SARS-CoV-2 infection

S-217622
Oral administration of S-217622 tablet once daily for 5 days
Placebo
Oral administration of placebo tablet once daily for 5 days

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

+81-3-3881-6116

May. 25, 2023

No

none