臨床研究等提出・公開システム

Japanese

Date of registration	June. 16, 2023
Last modified on	Mar. 12, 2024
Trial ID	jRCT2031230140

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

Contact for Scientific Queries	Name	Gomez Juan Carlos
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	Corporate Communications Department
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 16, 2023
Actual date of first enrollment		June. 29, 2023
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-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
	Exclusion Criteria	-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
	Age Minimum	6age old over
	Age Maximum	12age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		SARS-CoV-2 infection
Intervention(s)		S-217622 Oral administration of S-217622 tablet once daily for 5 days Placebo Oral administration of placebo tablet once daily for 5 days
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		-Adverse events, laboratory tests, vital signs -Plasma concentration of S-217622
Secondary Outcome(s)

Primary Sponsor	Shionogi & Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Adachi Kyousai Hospital Institutional Review Board
Address	1-36-8 Yanagihara, Adachi-ku, 120-0022 JAPAN, Tokyo
Telephone	+81-3-3881-6116
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 12, 2024	(this page)	Changes
1	June. 16, 2023	Detail

List of change history