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Introduction <p>Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is still an ongoing public health threat. COVID-19 can be accompanied by prolonged symptoms, known as “long COVID”, however, no pharmaceutical treatments are currently available for these symptoms. <i>Lactococcus lactis</i> strain Plasma (LC-Plasma; <i>Lactococcus lactis</i> subsp. <i>lactis</i> JCM 5805) directly activates human plasmacytoid dendritic cells (pDCs) and triggers antiviral immune responses. We hypothesized that LC-Plasma reduced SARS-CoV-2 viral load and eased symptoms in patients with mild COVID-19.</p> Methods <p>This PLATEAU study enrolled 100 patients with mild COVID-19 during Omicron BA.1 endemic, who were randomized into the LC-Plasma or placebo group in a 1:1 ratio and were observed for 14&#xa0;days. The primary endpoint was change in total score of eight subjective symptoms (fatigue, anorexia, headache, cough, shortness of breath, chest pain, smell, and taste disturbance). Secondary endpoints included each symptom, SARS-CoV-2 viral load, and pDCs.</p> Results <p>The primary endpoint did not show between-group differences. However, the proportion of patients without smell and taste disturbances was significantly higher in the LC-Plasma group on day 13 (<i>p</i>&#xa0;=&#xa0;0.030). The LC-Plasma group showed a significantly earlier decrease in SARS-CoV-2 viral load on day 4 (<i>p</i>&#xa0;&lt;&#xa0;0.001) and an increase in pDCs on day 8 (<i>p</i>&#xa0;=&#xa0;0.0498). Mild adverse events, such as diarrhea, cough-variant asthma, and urticaria, occurred in three (5.9%) patients in the LC-Plasma group.</p> Conclusions <p>The intake of LC-Plasma in patients with mild COVID-19 activates pDC, decreases SARS-CoV-2 viral load earlier, and may improve smell and taste disorders more quickly. LC-Plasma could be a safe, inexpensive, and easily accessible tool for the treatment of mild COVID-19.</p> Trial Registration <p>jRCTs071210097.</p> Graphical Abstract <p></p>

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Efficacy of Lactococcus lactis Strain Plasma in Patients with Mild COVID-19: A Multicenter, Double-Blinded, Randomized-Controlled Trial (PLATEAU Study)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月25日

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  • Kazuko Yamamoto,
  • Tsuyoshi Inoue,
  • Takaya Ikeda,
  • Toyomitsu Sawai,
  • Yosuke Nagayoshi,
  • Koji Hashiguchi,
  • Yoji Futsuki,
  • Yuichi Matsubara,
  • Yosuke Harada,
  • Nobuyuki Ashizawa,
  • Susumu Fukahori,
  • Naoki Iwanaga,
  • Takahiro Takazono,
  • Takashi Kido,
  • Hiroshi Ishimoto,
  • Naoki Hosogaya,
  • Noriho Sakamoto,
  • Masato Tashiro,
  • Takeshi Tanaka,
  • Chizu Fukushima,
  • Kenta Jounai,
  • Ryohei Tsuji,
  • Daisuke Fujiwara,
  • Kenji Ota,
  • Kosuke Kosai,
  • Akitsugu Furumoto,
  • Katsunori Yanagihara,
  • Koichi Izumikawa,
  • Hiroshi Mukae

摘要

Introduction

Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is still an ongoing public health threat. COVID-19 can be accompanied by prolonged symptoms, known as “long COVID”, however, no pharmaceutical treatments are currently available for these symptoms. Lactococcus lactis strain Plasma (LC-Plasma; Lactococcus lactis subsp. lactis JCM 5805) directly activates human plasmacytoid dendritic cells (pDCs) and triggers antiviral immune responses. We hypothesized that LC-Plasma reduced SARS-CoV-2 viral load and eased symptoms in patients with mild COVID-19.

Methods

This PLATEAU study enrolled 100 patients with mild COVID-19 during Omicron BA.1 endemic, who were randomized into the LC-Plasma or placebo group in a 1:1 ratio and were observed for 14 days. The primary endpoint was change in total score of eight subjective symptoms (fatigue, anorexia, headache, cough, shortness of breath, chest pain, smell, and taste disturbance). Secondary endpoints included each symptom, SARS-CoV-2 viral load, and pDCs.

Results

The primary endpoint did not show between-group differences. However, the proportion of patients without smell and taste disturbances was significantly higher in the LC-Plasma group on day 13 (p = 0.030). The LC-Plasma group showed a significantly earlier decrease in SARS-CoV-2 viral load on day 4 (p < 0.001) and an increase in pDCs on day 8 (p = 0.0498). Mild adverse events, such as diarrhea, cough-variant asthma, and urticaria, occurred in three (5.9%) patients in the LC-Plasma group.

Conclusions

The intake of LC-Plasma in patients with mild COVID-19 activates pDC, decreases SARS-CoV-2 viral load earlier, and may improve smell and taste disorders more quickly. LC-Plasma could be a safe, inexpensive, and easily accessible tool for the treatment of mild COVID-19.

Trial Registration

jRCTs071210097.

Graphical Abstract