Evaluation of the Efficacy of Probiotics Taken During the Acute Phase of COVID-19 to Reduce the Occurrence of Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 618
- 试验地点
- 2
- 主要终点
- Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19
研究概览
简要总结
Probiotics may be considered as an option of treatment for long COVID since they have anti-viral effect, trigger immunomodulation and have low side-effects. This randomized controlled trial aims to reduce the number of patients with long COVID by 25% 90 days after the COVID-19 diagnosis by taking probiotics in a symptomatic population, self-caring at home. During the acute phase of the disease, participants will take two capsules (probiotics or placebo) per day for 10 days and one capsule (probiotics or placebo) per day for the following 15 days. A follow-up will be done twice during the acute phase, 14 days and 28 days after starting to take the investigational product (compliance to treatment, side effects, etc.). At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, a questionnaire will be administered (COVID-19 symptoms, anxiety, functioning difficulties, etc.) and 2 saliva and 2 stool (viral and microbiota analyzes) self-samples will be performed.
详细描述
Rational:
COVID-19 disease caused by a new coronavirus (SARS-CoV-2) has received worldwide attention. No effective treatment against COVID-19 is available and the current vaccination appears essential to control the pandemic. However, many questions remain, such as the durability of immunity and the appearance of variants. While the acute phase has been widely studied, the long-term consequences are unknown, and a new burden is emerging: the long COVID. The long COVID is defined by the persistence of symptoms of the disease for more than 4 weeks after diagnosis. 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 and 3) probiotics are affordable and available with low side-effects.
Objectives:
Primary objective: Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19.
Secondary objectives (Obj S):
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
- •18 years and over
- •≤ 10 days between the COVID-19 diagnosis and the inclusion
- •Having symptoms of the COVID-19 at inclusion
- •Living in Quebec for the next 90 days
- •Self-caring at home
- •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 inclusion
- •Taking antibiotics for a reason other than COVID-19 at inclusion
- •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 randomized 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
Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19
时间窗: 90 days after the COVID-19 diagnosis.
COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)
次要结局
- Compare the proportion of patients presenting COVID-19 symptoms and severity of symptoms at D14, D30 and D90 by taking probiotics during the acute phase of COVID-19.(14,30 and 90 days after the COVID-19 diagnosis.)
- Describe the symptoms severity and evolution by study group and baseline characteristics.(Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis)
- Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).(Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis)