臨床研究等提出・公開システム

Date of registration	Aug. 18, 2026
Last modified on	Aug. 18, 2026
Trial ID	jRCT2071260072

Scientific Title	A phase 3 randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of secutrelvir in participants with COVID-19 who are at high risk for progression to severe disease (COVID-19)
Public Title	Phase 3 study of secutrelvir in participants with COVID-19 who are at high risk for progression to severe disease (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	GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 18, 2026
Target sample size		2000
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 years of age regardless of body weight. -Presence of risk factors for progression to severe COVID-19 at the time of screening. -Must have >= 1 of the COVID-19 signs/symptoms that is at least mild in severity and must still be present in the 24 hours prior to randomization. -Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test, of any respiratory tract specimen, collected <= 72 hours prior to randomization. -Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs. -Unable or unwilling to take other locally available COVID-19 antivirals.
	Exclusion Criteria	-Documented respiratory infection (eg, influenza, respiratory syncytial virus) other than COVID-19 within the 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 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization. -Current severely immunocompromised conditions.
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Intervention(s)		Oral administration of secutrelvir or placebo
Primary Outcome(s)		Proportion of participants experiencing any component of the following composite endpoint: targeted medically attended visits due to worsening COVID-19, all-cause hospitalizations, or all-cause deaths through day 28

Primary Sponsor	Shionogi & Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Mental Clinic Sakurazaka Institutional Review Board
Address	3-6-1 Kego, Chuo-ku, Fukuoka-shi, Fukuoka, Fukuoka
Telephone	+81-92-725-7900
Approval Status	Approval
Date of approval	July. 22, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	Argentina/Bulgaria/Denmark/Greece/Philippines/Poland/Romania/South Africa/Turkey/United States/Vietnam