Highly bioavailable curcumin in COVID-19 with no symptoms.

JRCT ID: jRCTs051210176

Registered date:18/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronavirus infection (COVID-19)
• Date of first enrollment: 18/02/2022
• Target sample size: 160
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

Combination of the following events
SpO2 progress to less than 96%, fever more than 37.5 degree Celsius, and death

Secondary Outcome

Each of the following events
SpO2 progress to less than 96%, fever more than 37.5 degree Celsius, and death

Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hasegawa Koji
• Source(s) of Monetary Support: Therabiopharma Inc.,Therabiopharma Inc.