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

Atsuhiro Kishimoto, Maki Komiyama, Hiromichi Wada, Noriko Satoh-Asahara, Hajime Yamakage, Yoichi Ajiro, Hiroki Aoyama, Yasuhiro Katsuura, Atsushi Imaizumi, Tadashi Hashimoto, Yoichi Sunagawa, Tatsuya Morimoto, Masashi Kanai, Hideaki Kakeya, Koji Hasegawa

Journal: Journal of health, population, and nutrition 2024;43(1):93

PMID: 38915116

Plain Language Summary

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Most COVID-19 patients are asymptomatic or mildly ill, but some develop hypoxemia (i.e., moderate disease), severe illness requiring ventilation (i.e., severe disease), and even succumb to multiple organ failure. This study aimed to evaluate the efficacy of cR [a highly absorbable curcumin] in preventing the progression of asymptomatic and mild COVID19 to moderate disease. This research was a double-blind randomised placebo-controlled study. Patients within 5 days of COVID-19 diagnosis were randomly assigned to a placebo or cR group. Results showed that cR reduced event occurrence by 47%, but the small number of cases made the results not statistically significant. However, cR still showed a trend of lowering event rates and reducing the use of fever medication. It also significantly lowered body temperature in patients with normal temperatures compared to a placebo. Authors concluded that their findings support the anti-inflammatory effects of cR in asymptomatic or mildly symptomatic patients with COVID-19.

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).

© 2024. The Author(s).

Address: Therabiopharma Inc., Kawasaki City, Kanagawa, Japan.; Clinical Research Institute, NHO Kyoto Medical Center, Kyoto City, Kyoto, Japan.; Department of Metabolic Syndrome and Nutritional Science, Research Institute of Environmental Medicine, Nagoya University, Nagoya City, Aichi, Japan.; Niijuku Co-Op Clinic, Tokyo, Japan.; Division of Clinical Research, National Hospital Organization Yokohama Medical Center, Yokohama City, Kanagawa, Japan.; Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka City, Shizuoka, Japan.; Graduate School of Medicine, Kyoto University, Kyoto City, Kyoto, Japan.; Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto City, Kyoto, Japan.; Clinical Research Institute, NHO Kyoto Medical Center, Kyoto City, Kyoto, Japan. [email protected].; Division of Clinical Research, National Hospital Organization Yokohama Medical Center, Yokohama City, Kanagawa, Japan. [email protected].

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