Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Time to hospital discharge
研究概览
简要总结
There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.
详细描述
The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.
Tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and a regulatory effect on the gastrointestinal metabolism.
The investigators will realize a prospective, double-blind, randomized trial to assess the effect of treatment with a dietary supplement (ARBOX), a molecular complex of quebracho and chestnut tannins extract and Vit B12, compared with placebo. 140 COVID-19 patients will be recruited in a single center in Buenos Aires Argentina. 70 patients will receive conventional treatment plus ARBOX (treated group) and 70 patients will receive conventional treatment plus placebo (control group). The effects will be evaluated during the 28 days follow up. The primary end point will be the time of discharge from the hospital. A panel of 27 cytokines level, intestinal microbiota composition and its metabolites will be assessed at day 1 and 14.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Over 18 years of age hospitalized in the general hospitalization room, who meet the definition of "Confirmed case COVID-19" (https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion -of-case)
排除标准
- •Pregnancy
- •Hypersensitivity to polyphenols
- •Patients unable to receive oral medication (severe cognitive impairment, assisted ventilation, impaired state of consciousness)
- •Lack of consent
- •Participation in any other interventional clinical trial
结局指标
主要结局
Time to hospital discharge
时间窗: Throughout the Study (Day 0 to Day 28)
defined as the time from first dose of polyphenol extract to hospital discharge
次要结局
- 28-day all-cause mortality(Throughout the Study (Day 0 to Day 28))
- Difference in Pro and antiinflammatory citoquine levels(day 1-14)
- Negativization of COVID-PCR at day 14(day 14)
- invasive ventilation on day 28(Throughout the Study (Day 0 to Day 28))
- Difference in fecal intestinal microbiota composition(day 1-14)
研究者
Maria Marta Piskorz
Neurogastroenterologist at Hospital de Clinicas, Principal Investigator
Hospital de Clinicas José de San Martín