PLATEAU study

JRCT ID: jRCTs071210097

Registered date:06/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronavirus disease 2019 (COVID-19)
• Date of first enrollment: 07/01/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 (4 capsules/time, once daily, after breakfast in principal) for 14 days

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Mukae Hiroshi
• Secondary Sponsor: Yamamoto Kazuko,Soiken Inc.