PLATEAU study

Conditions

coronavirus disease 2019 (COVID-19) SARS-CoV-2

Yamamoto K, Inoue T, Ikeda T, Sawai T, Nagayoshi Y, Hashiguchi K, Futsuki Y, Matsubara Y, Harada Y, Ashizawa N, Fukahori S, Iwanaga N, Takazono T, Kido T, Ishimoto H, Hosogaya N, Sakamoto N, Tashiro M, Tanaka T, Fukushima C, Jounai K, Tsuji R, Fujiwara D, Ota K, Kosai K, Furumoto A, Yanagihara K, Izumikawa K, Mukae H.

2025-10-25

10.1007/s40121-025-01246-8

552. Effect of <i>Lactococcus lactis strain plasma</i> (LC- Plasma) on immune response and symptoms in patients with mild COVID-19. Result of the multicenter, double- blinded, randomized controlled trial (PLATEAU study)

Kazuko Yamamoto, Tsuyoshi Inoue, Kenta Jounai, Ryohei Tsuji, Daisuke Fujiwara et al. (16 authors)

Open Forum Infectious Diseases2023-11-27

10.1093/ofid/ofad500.621

Efficacy of <i>Lactococcus lactis</i> strain plasma (LC-Plasma) in easing symptoms in patients with mild COVID-19: protocol for an exploratory, multicentre, double-blinded, randomised controlled trial (PLATEAU study)

Kazuko Yamamoto, Naoki Hosogaya, Tsuyoshi Inoue, Kenta Jounai, Ryohei Tsuji et al. (9 authors)

BMJ Open2022-09-012 citations

10.1136/bmjopen-2022-061172

Interventions

After obtaining their consent, the study subjects are randomly assigned into the following two groups

- Group A: oraly intake Lactococcus lactis strain Plasma-containing capsules (4 capsules/time, once daily, after breakfast in principal) for 14 days - Group B: oraly intake placebo-containing capsules

D013294

Lactococcus lactis strain Plasma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who meet all of the following criteria are included in this study: 1. Subjects who are SARS-CoV-2 positive 2. Subjects whose SpO2 is 96% or higher 3. Male or female who are aged of 20 years or older and younger than 65 years 4. Subjects who do not refuse to disclose their vaccination status 5. Subjects who can be recuperated at recuperation accommodations designated by Nagasaki prefecture* 6. Subjects who give their written consent form to participate in the study * Subjects who are decided to be hospitalized at giving their consent can be enrolled.

Exclusion criteria

Exclusion criteria: Subjects who fall into any of the following criteria are excluded from participating in the study: 1. Obese subjects (BMI >= 30 kg/m2) 2. Subjects who have strong dyspnea, chest pain, or bloody sputum 3. Subjects with history of COVID-19 4. Subjects who are being treated or will be treated by neutralizing antibody preparations 5. Subjects who are being treated by immunosuppressive agents, antirheumatic agents, corticosteroids, or immunoglobulin preparations at giving their consent 6. Subjects who are administered intestinal regulators orally 7. Subjects who are taking one or more beverage or foods that contain Lactococcus lactis strain Plasma or yogurt (that contain lactic acid bacteria or Lactobacillus bulgaricus) everyday 8. Subjects who are pregnant, possibly pregnant, or breastfeeding 9. Subjects who are participating in other clinical trials at giving their consent 10. Subjects who need legal representative for giving consent 11. Subjects with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame
Change in subjective symptoms* *Subjective symptoms (cough, shortness of breath, fatigue, headaches, anosmia, dysgeusia, and anorexia) are assessed by the Severity Score (4-point Likert scale, not affected, little affected, affected, and severely affected) or visual analog scale (VAS)	—

Secondary

Measure	Time frame
1. Change or percent change in viral load of SARS-CoV-2 2. Abundance ratio and absolute amount of plasmacytoid dendritic cells (pDCs) and change or percent change in biomarkers for pDC activation (HLA-DR, CD86) 3. Change or percent change in SARS-CoV-2-specific antibodies (IgG, IgM) 4. Change or percent change in blood cytokines (IL-6, MCP-1) 5.Change or percent change in interferon or interferon-stimulated antiviral factors in peripheral blood mononuclear cells (PBMCs) 6. Proportion of subjects who ambulatory visit the medical institutions or who are hospitalized.	—

Measure

Time frame

1. Change or percent change in viral load of SARS-CoV-2 2. Abundance ratio and absolute amount of plasmacytoid dendritic cells (pDCs) and change or percent change in biomarkers for pDC activation (HLA-DR, CD86) 3. Change or percent change in SARS-CoV-2-specific antibodies (IgG, IgM) 4. Change or percent change in blood cytokines (IL-6, MCP-1) 5.Change or percent change in interferon or interferon-stimulated antiviral factors in peripheral blood mononuclear cells (PBMCs) 6. Proportion of subjects who ambulatory visit the medical institutions or who are hospitalized.

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Contacts

Public ContactKazuko Yamamoto

Nagasaki University Hospital

kazukomd@nagasaki-u.ac.jp+81-95-819-7273

Outcome results

None listed