The Açaí Berry COVID-19 Anti-Inflammation Trial
关键词
抽象
描述
The current COVID-19 pandemic is caused by the novel coronavirus (SARS-Cov-2). The virus origins have been studied and evidence so far suggests it originates in bats, with spread to humans likely mediated by an intermediate mammalian. Bats have a dampened Nod-like receptor family, pyrin-containing 3 (NLRP3)-mediated inflammation. Dampening NLRP3-mediated inflammation has been associated with the asymptotic viral status, therefore it is plausible that the pathogenic inflammatory response of SARS-CoV-2 might be associated with activation of NLRP3 inflammasome. Data show that the natural extract of Açaí Palm Berry (Euterpe oleracea Mart.) is a potent inhibitor of NLRP3. This is a safe, inexpensive, and readily available natural health supplement which could be a rapid response treatment intervention for patients with COVID-19.
Our primary objective is to establish whether açai palm berry extract (Euterpe oleracea), given to community-dwelling adult patients diagnosed with COVID-19, compared to placebo, improves outcomes over 30 days on the 7-point ordinal scale described by Cao et al, and which is being used widely in COVID-19 trials with the aim of harmonizing endpoints. This study will be a prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial of Açaí Palm Berry extract in adult patients tested positive for SARS-Cov-2 in the last 7 days and that are currently being treated in the outpatient setting. The intervention group will receive 3 capsules of 520mg (one capsule every eight hours) of Acai Palm Berry extract (Nature's Way, NPN80038874) for 30 days. The non-intervention group will receive placebo pills, on top of standard clinical care. Our main endpoint will be the 7-point ordinal scale.
This project has the benefit of offering a safe and widely used natural extract as a potential treatment strategy to decrease inflammation and improve disease outcomes in patients with COVID-19. With no vaccine currently available, the search for effective treatments is a timely approach. The potential impact of such a therapeutic agent, if effective, can be quite vast given that it can be readily used by anyone and, most importantly, is affordable in many countries.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/23/2020 |
| 提交的预估入学人数: | 05/23/2020 |
| 首次发布: | 05/26/2020 |
| 上次提交的更新: | 05/23/2020 |
| 最近更新发布: | 05/26/2020 |
| 实际学习开始日期: | 04/30/2020 |
| 预计主要完成日期: | 10/31/2020 |
| 预计完成日期: | 04/30/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Açaí palm berry extract
Other: Placebo arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Açaí palm berry extract Açaí palm berry extract is a powerful antioxidant with no known side-effects and is widely consumed in Brazil. Açaí palm berry chemical composition has been established and includes several antioxidants - gallic acid, catechin, chlorogenic acid, caffeic acid, p-coumaric acid, epicatechin, orientin, cyanidin-3-0-glucoside, luteolin and apigenin. Orientin is the most concentrated compound (7,96mg/g) and this compound is able to modulate the NLRP3 inflammasome. | Dietary Supplement: Açaí palm berry extract Patients will be prescribed to take 1 capsule (520mg) of Açaí Palm Berry every 8 hours for a total of 3 capsules a day, during 30 days. Total dose: 1,560mg/day of Açaí Berry extract. |
| Placebo Comparator: Placebo arm This study will be double-blinded and placebo-controlled. To ensure double-blinding, placebo and active compound capsules will be over-encapsulated with DBCAPS® capsules, which were developed with a tamper-evident design to address the clinical trial challenges of testing without bias. These capsules are made of gelatin and have no interaction with bioavailability. | Other: Placebo arm Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days. |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Adults over 40 years of age; and - Tested positive for SARS-Cov-2 in the last 7 days; and - Being treated as an outpatient at the time of randomization. Exclusion Criteria: - Hospitalized patients; or - Patients who have known hypersensitivity to acai or acai-based products; or - Patients who are currently taking acai extract or juice; or - Patients with chronic severe renal impairment (creatinine clearance <30 mL/min or on renal replacement therapy); or - Pregnant or breastfeeding patients; or - Patients who have end-stage cancer or in whom imminent demise is anticipated and there is no commitment to active ongoing intervention; or - Patients who are unable to provide informed consent. |
结果
主要结果指标
1. 7-point ordinal symptom scale [30 days]
次要成果指标
1. The composite of all-cause mortality and need for mechanical ventilation [30 days]
2. The composite of all-cause mortality and hospitalization [30 days]
3. All-cause mortality [30 days]
4. Need for mechanical ventilation [30 days]
5. Need for hospitalization [30 days]
