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.

Highlights

  • COVID-19, which is caused by SARS-CoV-2 viral infection, originated in Wuhan, China, in December 2019 and has since spread all over the world

  • Each patient's recovery time was considerably shorter than reported for patients who received only standard care for SARS-CoV-2 infection

  • We demonstrate the prevention of disease progression and the significant improvement in the recovery process of COVID-19 patients using an oral administration of 5-aminolevulinic acid phosphate (5-ALA) with Sodium ferrous citrate (SFC) and the complete recovery of all the patients treated with 5-ALA and SFC

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Summary

Introduction

COVID-19, which is caused by SARS-CoV-2 viral infection, originated in Wuhan, China, in December 2019 and has since spread all over the world. Most of the casualties of COVID-19 pandemic were associated with severe pneumonia and multiorgan failure. The vaccinations for COVID-19 have been quickly developed worldwide (https://www.who.int/emergencies/diseases/novel-coronavirus2019/covid-19-vaccines), the pandemic seems to be not controlled in most of the countries due to the frequent mutations in SARS-CoV-2 genome RNA. 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

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