臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 18, 2022
Last modified on	Dec. 20, 2023
Trial ID	jRCTs051210176

Scientific Title	A double-blind, randomized placebo-controlled study evaluating the effect of highly bioavailable curcumin on prevention of disesase progression in coronavirus disease 2019 (COVID-19) patients with no symptoms. (Curcu-COVID study)
Public Title	Highly bioavailable curcumin in COVID-19 with no symptoms. (Curcu-COVID study)

Contact for Scientific Queries	Name	Hasegawa Koji
	Affiliation	National Hospital Organization Kyoto Medical Center
	Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Kyoto
	Telephone	+81-75-641-9161
	E-mail	koj@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Hasegawa Koji
	Affiliation	National Hospital Organization Kyoto Medical Center
	Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Kyoto
	Telephone	+81-75-641-9161
	E-mail	koj@kuhp.kyoto-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 18, 2022
Actual date of first enrollment
Target sample size		160
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Within 5 days after being diagnosed as COVID-19 by PCR test or antigen test (described in the guideline for medical treatment of COVID-19, 5.3 th edition (Ministry of Health, Labor and Welfare)). (2) Receiving no oxygen therapy and SpO2 is 96% or higher. (3) Body temperature is less than 37.5 degree Celsius. (4) Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1. (5) Age 20 years or older, both gender (6) Written informed consent was obtained.
	Exclusion Criteria	(1) Patients taking antithrombotic drugs (anticoagulants, EPA preparations, prostacyclin preparations) (2) Patients with a history of cerebral hemorrhage (3) Patients receiving oxygen therapy at home or dialysis (4) Patients with end-staged cancer (5) Patients taking steroids on a regular basis (6) Regular users of healthy foods containing curcumin (7) Patients with a history of allergies to curcumin (8) Pregnant women and those who are breastfeeding or may become pregnant (9) Patients who are scheduled to recieve neutralizing antibody therapy or anti-virus drugs. (10) Those who are judged by the principal investigator or the research coordinator to be inappropriate for participation in this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Coronavirus infection (COVID-19)
Intervention(s)		Arm highly bioavailable curcumin : curcuRougeTM (90mg/capsule), 4 capsules are given twice a day. (8 capsules/day, morning and evening) for 7 days. Arm placebo : 4 capsules are given twice a day, (8 capsules/day, morning and evening) for 7 days.
Health Condition(s) Keyword		Coronavirus infection (COVID-19)
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Combination of the following events SpO2 progress to less than 96%, fever more than 37.5 degree Celsius, and death
Secondary Outcome(s)		Each of the following events SpO2 progress to less than 96%, fever more than 37.5 degree Celsius, and death Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Therabiopharma Inc.
Secondary Sponsor	Not applicable

Source of Monetary Support	Therabiopharma Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nara Medical University Certified Review Board
Address	840 Shijo-Cho, Kashihara, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Approval Status	Approval
Date of approval

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 20, 2023	(this page)	Changes
1	Feb. 18, 2022	Detail

List of change history