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Randomized Controlled Trial
. 2024 Jun 24;43(1):93.
doi: 10.1186/s41043-024-00584-6.

Efficacy of highly bioavailable oral curcumin in asymptomatic or mild COVID-19 patients: a double-blind, randomized, placebo-controlled trial

Atsuhiro Kishimoto  1   2 , Maki Komiyama  2 , Hiromichi Wada  2 , Noriko Satoh-Asahara  2   3 , Hajime Yamakage  2 , Yoichi Ajiro  4   5 , Hiroki Aoyama  1 , Yasuhiro Katsuura  1 , Atsushi Imaizumi  1 , Tadashi Hashimoto  1 , Yoichi Sunagawa  2   6 , Tatsuya Morimoto  2   6 , Masashi Kanai  7 , Hideaki Kakeya  8 , Koji Hasegawa  9   10
Affiliations
Randomized Controlled Trial

Efficacy of highly bioavailable oral curcumin in asymptomatic or mild COVID-19 patients: a double-blind, randomized, placebo-controlled trial

Atsuhiro Kishimoto et al. J Health Popul Nutr. .

Abstract

Introduction: Even after the peak of the COVID-19 pandemic, the number of mild cases remains high, requiring continuous control. Curcumin, owing to its anti-inflammatory properties, can suppress vital proliferation and cytokine secretion in animal models. We developed a highly absorbable curcumin, curcuRouge® (cR), which is approximately 100 times more orally bioavailable than conventional curcumin. We evaluated the effect of cR on the inhibition of disease progression in asymptomatic or mildly symptomatic COVID-19 patients.

Methods: This study evaluated the effect of 7-day oral intake of cR (360 mg twice daily). Patients within 5 days of COVID-19 diagnosis were randomly assigned to a placebo or cR group in a double-blind manner.

Results: Primary endpoint events [body temperature (BT) ≥ 37.5 °C and saturation of percutaneous oxygen (SpO2) < 96%] were fewer than expected, and the rate of these events was 2.8% in the cR group (2/71) and 6.0% in the placebo group (4/67); hazard ratio (HR) = 0.532, 95% confidence interval (CI) 0.097-2.902. Patients receiving cR tended to take fewer antipyretic medications than those receiving placebo (HR = 0.716, 95% CI 0.374-1.372). Among patients with a normal range of BT at baseline, the BT change rate was significantly (p = 0.014) lower in the cR group (- 0.34%) versus placebo (- 0.01%).

Conclusion: The relative suppression of event rates and antipyretic medications taken, and significant decrease of subclinical BT support the anti-inflammatory effects of cR in asymptomatic or mildly symptomatic patients with COVID-19.

Trial registration: Japan Registry of Clinical Trials (CRB5200002).

Keywords: Body temperature; COVID-19; Clinical trial; Curcumin; Saturation of percutaneous oxygen; curcuRouge®.

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Conflict of interest statement

This study was funded by a joint research agreement between NHO Kyoto Medical Center and Therabiopharma Inc. M. Kanai and H. Kakeya own equity and they are the scientific consultants of Therabiopharma Inc.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Kaplan–Meier curves of primary end points (SpO2 < 96 or body temperature ≥ 37.5℃) in placebo and curcuRouge® groups
Fig. 3
Fig. 3
Percentage changes of body temperature from Day-1 to Day-7 in the placebo (n = 64) and curcuRouge® (n = 66) groups
See this image and copyright information in PMC

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