NCT05474144已完成不适用
A Two-arm, Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy of the Probiotic Dietary Supplement SmartProbio C in the Supportive Supplementation of Patients With a Complicated Course of COVID-19 Infection
Medi Pharma Vision4 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Gut microbiome
研究概览
简要总结
The aim of the study is to test the efficacy of the probiotic SmartProbio C in patients with a severe course of COVID-19 infection. Patients were randomly divided into two arms between the probiotic group and the placebo group. They were further divided into four groups according to 1) BMI (Body mass index; <=30/>30), 2) age (<=65/>65), 3) CRP (C-reactive protein; <=100/>100), 4) chronic lung disease (yes/no). Gut microbiome analysis and its changes in selected parameters (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint. Other assessed indicators include:
- Tracking of time to clinical improvement by two points on a seven-point ordinal scale for clinical improvement according to R&D Blueprint: COVID-19 Therapeutic Trial Synopsis (WHO, 2020) or time to hospital discharge (whichever comes first)
- Monitoring the length of oxygen dependence
- Monitoring of laboratory markers of inflammation - serum peripheral blood CRP levels
- Monitoring of mortality
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is willing and able to provide informed consent prior to any study procedure.
- •Age at the time of screening between 18 and 85 years inclusive.
- •Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or immunochromatographic detection of SARS CoV-2 specific antigens no more than three days prior to randomization.
- •COVID-19 symptoms lasting less than or equal to seven days, including.
- •Subject is currently hospitalized and requires medical care due to COVID-19 disease and was admitted at most two days prior to randomization.
- •Peripheral blood oxygen saturation <94% on air (as measured by pulse oximetry or arterial blood sampling) at the time of inclusion in the trial.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19 disease.
- •Concomitant treatment of COVID-19 with other non-standard-of-care medications less than 24 hours prior to initiation of the study intervention dosing (excluding remdesivir, corticosteroids, casirivimab, imdevimab, or bamlanivimab).
- •Immunosuppressant treatment three months prior to hospital admission (excluding topical and inhaled corticosteroids or systemically administered corticosteroids at a dose equivalent to <40 mg Prednisone)
- •Necessity of invasive pulmonary ventilation.
- •Patients with known primary or secondary immunodeficiency.
- •History of Crohn's disease or ulcerative colitis.
- •Abnormal screening laboratory results - laboratory abnormalities that, in the opinion of the investigator, will interfere with completion of participation in the clinical trial or will interfere with the results of the trial.
- •Participation in another clinical trial of a drug or medical device, or less than 30 days have elapsed since the completion of participation in another trial or use of the investigational drug or device.
- •Other probiotic supplementation.
- •Hypersensitivity to any ingredient of a product administered during a clinical trial.
- •Women who are pregnant or breastfeeding.
- •Patients with preterminal and terminal organ failure (COPD GOLD 3 and 4, CKD G4 and G5, NYHA 3 and 4).
- •Any condition that, in the opinion of the investigator, may compromise the patient's ability to provide informed consent and/or comply with all required study procedures.
结局指标
主要结局
Gut microbiome
时间窗: The first sample was taken at the beginning of hospitalization before the start of supplementation, the second at discharge from the hospital, but not later than on the 14th day of hospitalization.
Changes in selected parameters of gut microbiome (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, and Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint.
次要结局
- CRP (C-reactive protein) monitoring(On the first day of admission to hospital and on the day of hospital discharge, but no later than 14th day)
- Monitoring the length of oxygen dependence(From the beginning of the provision of HFOT (high flow oxygen therapy) to the end of the provision of HFOT)
- Length of hospitalisation(From the date of admission to hospital until discharge from hospital or above defined two point improvement, whichever comes first)
- Monitoring mortality rates(From the date of admission to hospital until discharge from hospital or death, whichever comes first)
研究者
研究点 (4)
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