• Takeshi Tanaka, Masato Tashiro, Kenji Ota, Ayumi Fujita, Toyomitsu Sawai, Junichi Kadota, Yuichi Fukuda, Makoto Sumiyoshi, Shotaro Ide, Natsuo Tachikawa, Hiroshi Fujii, Makoto Hibino, Hisanori Shiomi, Mai Izumida, Kohsuke Matsui, Momoko Yamauchi, Kensuke Takahashi, Hirotomo Yamanashi, Takashi Sugimoto, Shogo Akabame, Masataka Umeda, Masumi Shimizu, Naoki Hosogaya, Kosuke Kosai, Kazuaki Takeda, Naoki Iwanaga, Nobuyuki Ashizawa, Tatsuro Hirayama, Takahiro Takazono, Kazuko Yamamoto, Yoshifumi Imamura, Taiga Miyazaki, Yusuke Kobayashi, Koya Ariyoshi, Hiroshi Mukae, Katsunori Yanagihara, Kiyoshi Kita, and Koichi Izumikawa.
• Infection Control and Education Center, Nagasaki University Hospital, Nagasaki-shi, Nagasaki, Japan.
• Medicine (Baltimore). 2023 Aug 25; 102 (34): e34858e34858.

Background5-aminolevulinic acid (5-ALA), a natural amino acid that is marketed alongside sodium ferrous citrate (SFC) as a functional food, blocks severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) proliferation in vitro and exerts anti-inflammatory effects. In this phase II open-label, prospective, parallel-group, randomized trial, we aimed to evaluate the safety and efficacy of 5-ALA in patients with mild-to-moderate coronavirus disease 2019.MethodsThis trial was conducted in patients receiving 5-ALA/SFC (250/145 mg) orally thrice daily for 7 days, followed by 5-ALA/SFC (150/87 mg) orally thrice daily for 7 days. The primary endpoints were changes in SARS-CoV-2 viral load, clinical symptom scores, and 5-ALA/SFC safety (adverse events [AE] and changes in laboratory values and vital signs).ResultsA total of 50 patients were enrolled from 8 institutions in Japan. The change in SARS-CoV-2 viral load from baseline was not significantly different between the 5-ALA/SFC (n = 24) and control (n = 26) groups. The duration to improvement was shorter in the 5-ALA/SFC group than in the control group, although the difference was not significant. The 5-ALA/SFC group exhibited faster improvement rates in "taste abnormality," "cough," "lethargy," and "no appetite" than the control group. Eight AEs were observed in the 5-ALA/SFC group, with 22.7% of patients experiencing gastrointestinal symptoms (decreased appetite, constipation, and vomiting). AEs occurred with 750/435 mg/day in 25.0% of patients in the first phase and with 450/261 mg/day of 5-ALA/SFC in 6.3% of patients in the second phase.Conclusion5-ALA/SFC improved some symptoms but did not influence the SARS-CoV-2 viral load or clinical symptom scores over 14 days. The safety of 5-ALA/SFC in this study was acceptable. Further evaluation using a larger sample size or modified method is warranted.Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.

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