Evaluation of the Efficacy of Probiotics to Reduce the Duration and Symptoms of COVID-19 (PROVID-19 Study): a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Duration of symptoms of the COVID-19
研究概览
简要总结
COVID-19 disease caused by a new coronavirus (SARS-CoV-2) has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available. Probiotics may be considered as an option of treatment since they have anti-viral effect, trigger immunomodulation and have low side-effects.
This randomized controlled trial aims to evaluate the efficacy of probiotics to reduce the duration and symptoms of COVID-19 in a symptomatic population tested positive to SARS-CoV-2, self-caring at home.
详细描述
Rational: COVID-19 disease is caused by a new coronavirus (SARS-CoV-2) and has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available so far. Several strong arguments support the study of probiotics for COVID-19: 1) probiotics act on viruses by various well described mechanisms (reduction of absorption, cellular internalization of the virus, production of metabolites / substances having a direct antiviral effect; and immunomodulation); 2) probiotics are considered with a high level of evidence (meta-analysis) to reduce diarrhea (associated with antibiotics and Clostridium difficile) and for respiratory tract infections; 3) probiotics are affordable and available with low side-effects.
Objectives:
- Evaluate the effect of probiotics on the duration of COVID-19 in symptomatic patients, with moderate forms of the disease.
- Evaluate the effect of probiotics on the severity of COVID-19 in symptomatic patients, with moderate forms of the disease.
- Evaluate the effect of probiotics on the evolution of oral and fecal microbiota in symptomatic patients, with moderate forms of the COVID-19 disease.
Population: Men and women, 18 years or older, with a first positive test for COVID-19 in the last 5 days, having symptoms of the COVID-19, self-caring at home, living in Quebec for the next 60 days, able to take medication alone, with access to a phone or to the Internet.
Material: After providing consent remotely (electronic or recorded by phone), patients will receive by mail at home: : a leaflet explaining the study, the study product (probiotics or placebo) for 25 days, a container of maple syrup and a cup, a thermometer, an oximeter, a logbook, 2 saliva sample self-collection kits, 2 stool sample self-collection kits and instruction sheets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First positive test for COVID-19 in the last 5 days;
- •Having symptoms of the COVID-19 at enrollment;
- •Self-caring at home;
- •Living in Quebec for the next 60 days;
- •Able to take medication alone;
- •With access to a phone or to the Internet;
- •Able to give informed consent.
排除标准
- •Taking probiotic supplements at enrollment;
- •Taking antibiotics for a reason other than COVID-19 at enrollment;
- •Allergies to soy, lactose, yeast, maltodextrin, vitamin C, potato starch, magnesium stearate, hypromellose or titanium dioxide;
- •Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
- •Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
- •Has active cancer;
- •Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
- •Already participating in another clinical trial;
- •Is pregnant, expects to become pregnant in the next few months or is breastfeeding;
- •Has any other condition that would prevent safe participation in the study.
结局指标
主要结局
Duration of symptoms of the COVID-19
时间窗: During the period of the treatment (from Day 1 to Day 25)
Number of days before symptoms disappear
次要结局
- Evolution of oral and fecal microbiota(At Day 1 (baseline) and Day 10 of the treatment)
- Severity of the COVID-19(During the period of the study, first day in (at randomization) to last day in (last follow-up 30 days after the end of treatment) (from Day 1 to Day 55))