RESEARCH ARTICLE


Case Reports: Safety, Tolerability, and Efficacy of 5-Aminolevulinic Acid Phosphate, an Inducer of Heme Oxygenase 1, in Combination with Sodium Ferrous Citrate for the Treatment of COVID-19 Patients



Kazutoshi Kaketani1, *
iD
, Motowo Nakajima2
iD

1 Hanzomon Gastrointestinal Clinic, Tokyo 102-0083, Japan
2 SBI Pharmaceuticals Co. Ltd., Tokyo 106-6020, Japan


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Creative Commons License
© 2021 Kaketani and Nakajima.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: (https://creativecommons.org/licenses/by/4.0/legalcode). This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at Hanzomon Gastrointestinal Clinic, 1-7-25 Kojimachi, Choyoda-ku, Tokyo 102-0083, Japan; Tel: +81-3-3265-5566; Fax: +81-3-3265-5568; E-mail: hanzomon.ap@email.plala.or.jp


Abstract

Background:

The COVID-19 pandemic is the greatest life-threatening disaster currently facing the worldwide population. COVID-19 patients with concomitant diseases such as chronic obstructive pulmonary disease and cardiovascular problems quickly develop severe pneumonia with low arterial oxygen saturation and multiorgan failure, resulting in sudden death. These symptoms are caused by deadly inflammation that occurs in various organs.

Objective:

Various types of inflammation caused by RNA virus infection have been known to be manageable by the induction of heme oxygenase-1 (HO-1) in local tissues. HO-1 is also known to be a key enzyme for the suppression of RNA viral replication. Therefore, in addition to standard medical care for pneumonic viral infection, we have attempted to treat COVID-19 patients with a highly effective HO-1 inducer, 5-aminolevulinic acid phosphate, in combination with ferrous sodium citrate (5-ALA with SFC).

Methods:

5-ALA with SFC is a supplement formulation registered in Japan as food with functional claims. Six patients with typical symptoms of COVID-19 and some suspected COPD associated with heavy smoking were given oral administration of multiple doses of 5-ALA with SFC at the Maximum Tolerated Dose (MTD) for 3 to 7 days, followed by treatment with a lower amount of 5-ALA with SFC for 2 to 3 weeks.

Results and Conclusion:

Each patient's recovery time was considerably shorter than reported for patients who received only standard care for SARS-CoV-2 infection. The results confirm the safety, tolerability, and efficacy of 5-ALA with SFC as a therapeutic supplement for patients with acute-phase COVID-19.

Keywords: COVID-19, SARS-CoV-2, 5-aminolevulinic acid phosphate (5-ALA), Sodium ferrous citrate (SFC), Heme, Heme oxygenase-1 (HO-1), Anti-virus therapy, Maximum tolerated dose (MTD).