Publication of a Paper on the Improvement Trend of Post-COVID-19 Sequelae by Continuous Intake of 5-Aminolevulinic Acid (5-ALA)

Improvement Trends Observed in Post-COVID-19 Symptoms Following Continuous Intake of 5-ALA (Aminolevulinic Acid)

We are pleased to announce that the IT Healthcare Social Cooperation Course at the Graduate School of Pharmaceutical Sciences, University of Tokyo*1 (hereinafter referred to as ITHC, chaired by Professor Kyoko Imamura) and NeoPharma Japan Co., Ltd.*2 (located at 6-2-6 Kojimachi, Chiyoda-ku, Tokyo, CEO Satoshi Kawada: hereinafter referred to as NPJ), conducted a safety trial on patients exhibiting symptoms of post-COVID-19 syndrome (hereinafter referred to as “post-COVID-19 sequelae”) at Tokyo Center Clinic. The study observed improvement effects on fatigue and states of anxiety or gloom in a group that ingested 5-aminolevulinic acid phosphate*3 (hereinafter referred to as “5-ALA phosphate”) and sodium ferrous citrate (hereinafter referred to as “SFC”).

This research was published in the journal “ALA-Porphyrin Science” on March 24, 2022 (Japan time).

 

【URL】

https://porphyrin-ala.com/wp-content/uploads/2021_2.pdf

 

【Research Highlights】

– Individuals with post-COVID-19 sequelae ingested capsules containing 5-ALA phosphate (50mg) + SFC (29mg) at a daily dose of six capsules for 28 consecutive days, confirming the safety of the product.

– Statistically significant improvements in fatigue and states of anxiety or gloom were observed in individuals with post-COVID-19 sequelae who continuously ingested 5-ALA phosphate and SFC.

– The use of smart devices for behavioral monitoring demonstrated the utility of remote clinical studies.

 

【Overview】

While COVID-19, which began in 2020, usually resolves within weeks, symptoms persist in some cases, with a variety of manifestations. As of the end of January 2022, 1.5 million people in the UK reported experiencing some form of sequelae symptoms*4. In Japan, an increasing number of cases report post-COVID-19 fatigue as a significant issue, emerging as a new societal challenge.

5-ALA phosphate and SFC have been shown to reduce fatigue in healthy individuals in previous studies. To ensure safety, a safety trial was conducted specifically for patients with post-COVID-19 sequelae.

In 21 cases with post-COVID-19 sequelae, the safety of ingesting capsules containing 5-ALA phosphate (300mg) + SFC (174mg) daily for 28 consecutive days was evaluated. Additionally, the impact on post-COVID-19 sequelae was assessed using electronic diaries and smartwatches for behavioral monitoring, exploring the utility of remote clinical studies.

The results confirmed the safety of the same dose in people with post-COVID-19 sequelae. Despite a small number of subjects, statistically significant improvements in fatigue and states of anxiety or gloom were observed before and after ingestion of the test food.

With the rapid spread of the COVID-19 Omicron variant, an increase in individuals experiencing sequelae is expected, necessitating further validation in a larger cohort.

 

【Paper Title and Authors】

Title

Phase 2 randomized clinical trial of 5-Aminolevulinic acid plus sodium citrate chloride vs placebo for Covid-19 infected patients recovered with sequelae

Authors

Kyoko Imamura (Special Appointed Professor, IT Healthcare Social Cooperation Course, Graduate School of Pharmaceutical Sciences, University of Tokyo) Hidemitsu Sugihara (Special Appointed Researcher, IT Healthcare Social Cooperation Course, Graduate School of Pharmaceutical Sciences, University of Tokyo) Koichi Hirahata (Director, Hirahata Clinic)

 

Published in

ALA-Porphyrin Science, Vol. 10 No 1 2021, 15-22

 

【Glossary】

*1 IT Healthcare Social Cooperation Course, Graduate School of Pharmaceutical Sciences, University of Tokyo

Established in November 2018, the IT Healthcare Social Cooperation Course at the Graduate School of Pharmaceutical Sciences, University of Tokyo aims to conduct joint research on the innovation of drug development and proper use through ICT utilization. It focuses on building regulatory science for data reliability necessary for conducting home/remote clinical trials, organizing medication information and ICT education for pharmacists, developing educational programs for leadership in patient-centered drug development, and achieving real-world data analysis and clinical epidemiology for medical innovation. Ultimately, it contributes to enhancing the quality of life, treatment, and everyday living for the populace.

https://plaza.umin.ac.jp/ithc-utokyo/

 

*2 NeoPharma Japan Co., Ltd.

NeoPharma Japan Co., Ltd. was established through a joint venture between Neopharma LLC, based in the United Arab Emirates (UAE), and Neo ALA Co., Ltd. (formerly Cosmo ALA Co., Ltd.). The NeoPharma Group, headquartered in the UAE, is an international pharmaceutical company that operates manufacturing and sales of medicines primarily in emerging countries in the Middle East. NeoPharma Japan plays a crucial role in Neopharma LLC’s overseas strategy in pharmaceutical manufacturing. Additionally, by advancing research and development for various applications of 5-aminolevulinic acid (5-ALA), NeoPharma Japan creates new added value for the entire group.

https://www.neopharmajp.co.jp/

 

*3 5-Aminolevulinic acid phosphate

Based on a 2013 notification by the Ministry of Health, Labour and Welfare, “5-aminolevulinic acid phosphate (produced by photosynthetic bacteria Rhodobacter sphaeroides)” is considered a substance that is not solely judged as a pharmaceutical as long as it does not claim pharmacological effects. Our company manufactures and sells 5-aminolevulinic acid phosphate in compliance with the Food Sanitation Act.

 

*4 Report issued by the UK National Statistics Office on March 2, 2022

Prevalence of ongoing symptoms following coronavirus (COVID-19) infection in the UK : 3 March 2022 https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditions anddiseases/bulletins/prevalenceofongoingsymptomsfollowingcoronaviruscovid19infectio nintheuk/3march2022