臨床研究等提出・公開システム

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)

Highly bioavailable curcumin in COVID-19 with no symptoms. (Curcu-COVID study)

153

Of the 153 participants in this study, 8 were excluded due to progression of disease or missing data before ingesting the test food. An additional 7 patients were subsequently excluded as ineligible cases, leaving 138 participants in the study, 71 in the curcuRouge group and 67 in the placebo group. As background information, the age and gender of the subjects were 48.0 years, 27 males and 43 females in the curcuRouge group, and 46.5 years, 23 males and 41 females in the placebo group. The number of days from confirmation of COVID-19 infection to initiation of treatment was 3.5 days in the curcuRouge group and 3.7 days in the placebo group. In addition, SpO2 and body temperature were 97.9 and 36.3 in the curcuRouge group, and 98.0 and 36.1 in the placebo group. Regarding background factors between the two groups, body temperature was significantly higher in the curcuRouge group, but no statistically significant differences were observed in other factors.

The registration pace was more or less in line with expectations compared to the initially predicted pace. The number of patients involved was 153, and excluding 8 patients whose COVID-19 disease had progressed and deviated from the inclusion criteria before allocation, 145 patients were dynamically assigned to the curcuRouge group or the placebo group.. Furthermore, 7 ineligible cases (3 in the curcuRouge group and 4 in the placebo group) who deviated from the inclusion criteria after the fact were excluded from the analysis, leaving 71 in the curcuRouge group and 67 in the placebo group. Regarding regular reporting, the CRB review result notification dated May 13, 2024 was reported to the Minister of Health, Labor and Welfare on July 1, 2024, and there were non-conformities that occurred more than one month from the date of issue.

In both curcuRouge and placebo groups, there were no adverse events that could be attributed to the test food.

In this study, we set the occurrence of a composite event (progression to SpO2 below 96, progression to temperature 37.5 or higher, hospitalization, death at home or during overnight treatment) as the primary endpoint of efficacy, and compared it to the placebo group. We verified whether the proportion of patients who experienced an event was lower in the curcuRouge group. As a result, 4 patients (6%) in the placebo group and 2 patients (2.8%) in the curcuRouge group experienced a drop in SpO2 below 96 or a rise in body temperature above 37.5, and no patients were hospitalized or died. Ta. In addition, the change in body temperature at the end of the study for patients whose body temperature was normal at the start of the study was -0.34% in the curcuRouge group and -0.01% in the placebo group, which was a significant change in body temperature in the curcuRouge group compared to the placebo group. (p=0.014).

In asymptomatic and mildly ill patients with COVID-19 infection, curcuRourge, an highly oral absorbable curcumin formulation, tended to reduce event rates, as measured by progression to SpO2 less than 96 or body temperature 37.5 or more, compared to placebo. In addition, the curcuRouge significantly reduced body temperature compared to placebo. There were no adverse events that could be attributed to the test food.

Oct. 08, 2024

June. 27, 2024

https://pubmed.ncbi.nlm.nih.gov/38915116/

No

No plans at the moment.

https://jrct.niph.go.jp/latest-detail/jRCTs051210176

Hasegawa Koji

National Hospital Organization Kyoto Medical Center

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Kyoto

koj@kuhp.kyoto-u.ac.jp

Hasegawa Koji

National Hospital Organization Kyoto Medical Center

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Kyoto

+81-75-641-9161

koj@kuhp.kyoto-u.ac.jp

Complete

Feb. 18, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

(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.

(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.

Both

Coronavirus infection (COVID-19)

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.

Coronavirus infection (COVID-19)

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

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

Adverse events

+81-744-29-8835

Feb. 03, 2022

none