臨床研究等提出・公開システム

Date of registration	Aug. 10, 2023
Last modified on	Aug. 19, 2025
Trial ID	jRCT2031230285

Scientific Title	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants (OAKTREE) (OAKTREE)
Public Title	Study of GS-5245 in Nonhospitalized Participants With COVID-19 (OAKTREE)

Contact for Scientific Queries	Name	Ueda Hiroki
	Affiliation	Gilead Sciences
	Address	Gran Tokyo South Tower, 1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5539-1946
	E-mail	JPClinicalOperations@gilead.com
Contact for Public Queries	Name	Clinical Operations
	Affiliation	Gilead Sciences
	Address	Gran Tokyo South Tower, 1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5539-1946
	E-mail	JPClinicalOperations@gilead.com

Recruitment status	Complete


Anticipated date of first enrollment		Aug. 31, 2033
Target sample size		1900
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	Aged 18 to 65 years Willing and able to provide written informed consent. SARS CoV 2 infection confirmed, 3 days before randomization Initial onset of COVID19 signs/symptoms 3 days before randomization Not currently hospitalized or requiring hospitalization.
	Exclusion Criteria	Any risk factors for progression to severe disease. Received an approved, authorized, or investigational COVID-19 vaccine (including booster dose) < 120 days before randomization. Self-reported COVID-19 diagnosis < 120 days before randomization. Anticipated need for hospitalization < 48 hours after randomization. Positive urine pregnancy test at screening.
	Age Minimum	18age old over
	Age Maximum	65age old not
Health Condition(s) or Problem(s) Studied		Infectious disease caused by the SARS-CoV-2
Intervention(s)		Experimental: GS-5245 Participants will receive GS-5245 350 mg twice daily for 5 days. Placebo Comparator: Placebo Participants will receive GS-5245 placebo twice daily for 5 days.
Health Condition(s) Keyword		COVID19
Primary Outcome(s)		Time to COVID 19 symptom alleviation by Day 29
Secondary Outcome(s)		Time to COVID-19 symptom resolution by Day 29 Proportion of participants with COVID19 related MAVs or all cause death by Day 29 Proportion of participants with moderate relapse of COVID19 symptoms by Day 29 Proportion of participants with COVID19 related hospitalization or all cause death by Day 29 Change from baseline in SARS CoV 2 nasal swab viral load at Day 5 Time to antigen negativity Proportion of participants with viral antigen rebound Plasma concentrations and PK parameters AUCtau, Ctau, and Cmax of GS 441524, as available Proportion of participants with relapse of COVID19 symptoms by Day 29

Primary Sponsor	Gilead Sciences

Name of Certified Review Board	-
Address	-, Tokyo

Plan to share IPD	No

Secondary ID(s)	NCT05715528
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	US/Canada

History of Changes

No	Publication date
3	Aug. 19, 2025	(this page)	Changes
2	Jan. 13, 2024	Detail	Changes
1	Aug. 10, 2023	Detail

List of change history