COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs071210097

Kazuko Yamamoto

kazukomd@nagasaki-u.ac.jp

2021-12-06

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Subjects who meet all of the following criteria are included in this study:1. Subjects who are SARS-CoV-2 positive2. Subjects whose SpO2 is 96% or higher3. Male or female who are aged of 20 years or older and younger than 65 years4. Subjects who do not refuse to disclose their vaccination status5. 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.

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 sputum3. Subjects with history of COVID-194. Subjects who are being treated or will be treated by neutralizing antibody preparations5. Subjects who are being treated by immunosuppressive agents, antirheumatic agents, corticosteroids, or immunoglobulin preparations at giving their consent6. Subjects who are administered intestinal regulators orally7. 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) everyday8. Subjects who are pregnant, possibly pregnant, or breastfeeding9. Subjects who are participating in other clinical trials at giving their consent10. Subjects who need legal representative for giving consent11. Subjects with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

2

Yamamoto Kazuko

20

65

Japan

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

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)

Not reported

[{"arm_notes": "", "treatment_id": 2116, "treatment_name": "Lactococcus lactis strain plasma", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]