Safety and efficacy of 5-aminolevulinic acid phosphate/iron in mild-to-moderate coronavirus disease 2019: A randomized exploratory phase II trial Article Swipe
Takeshi Tanaka
,
Masato Tashiro
,
Kenji Ota
,
Ayumi Fujita
,
Toyomitsu Sawai
,
Jun‐ichi 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
,
Koichi Izumikawa
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1097/md.0000000000034858
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1097/md.0000000000034858
Background: 5-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. Methods: This 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). Results: A 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. Conclusion: 5-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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1097/md.0000000000034858
- OA Status
- gold
- Cited By
- 5
- References
- 53
- Related Works
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- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4386279260Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1097/md.0000000000034858Digital Object Identifier
- Title
-
Safety and efficacy of 5-aminolevulinic acid phosphate/iron in mild-to-moderate coronavirus disease 2019: A randomized exploratory phase II trialWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-08-25Full publication date if available
- Authors
-
Takeshi Tanaka, Masato Tashiro, Kenji Ota, Ayumi Fujita, Toyomitsu Sawai, Jun‐ichi 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, Koichi IzumikawaList of authors in order
- Landing page
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https://doi.org/10.1097/md.0000000000034858Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1097/md.0000000000034858Direct OA link when available
- Concepts
-
Medicine, Lethargy, Adverse effect, Vomiting, Internal medicine, Randomized controlled trial, Gastroenterology, Constipation, Nausea, Tolerability, Diarrhea, Clinical trial, Viral load, Immunology, Human immunodeficiency virus (HIV)Top concepts (fields/topics) attached by OpenAlex
- Cited by
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5Total citation count in OpenAlex
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2025: 2, 2024: 3Per-year citation counts (last 5 years)
- References (count)
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53Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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