臨床研究等提出・公開システム

Date of registration	July. 21, 2026
Last modified on	July. 21, 2026
Trial ID	jRCT2031260334

Scientific Title	A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of secutrelvir in participants with COVID-19 (COVID-19)
Public Title	Phase 3 study of secutrelvir in participants with COVID-19 (COVID-19)

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		July. 21, 2026
Target sample size		1200
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	Must be 12 to < 18 years of age with a body weight >= 40 kg, or >= 18 and < 75 years of age regardless of body weight. Must have >= 1 of the following COVID-19 symptoms, present within 24 hours prior to randomization. Confirmed SARS-CoV-2 infection as determined by any SARS-CoV-2 test from any respiratory tract specimen, collected <= 48 hours prior to randomization. Must be randomized within 48 hours of COVID-19 symptom onset.
	Exclusion Criteria	Documented respiratory infection (eg, influenza, respiratory syncytial virus infection) other than COVID-19 within 14 days prior to the screening visit. Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.
	Age Minimum	12age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Intervention(s)		Oral administration of secutrelvir or placebo
Primary Outcome(s)		Time to first resolution of 14 COVID-19 symptoms through day 21

Primary Sponsor	Shionogi & Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8 Minami-Ku, Yokohama-City, Kanagawa, Kanagawa
Telephone	+81-45-722-8655
E-Mail	morimoto.aimi830@eps.co.jp
Approval Status	Approval
Date of approval	June. 12, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	Vietnam/Thailand/Philippines/Taiwan