The Açaí Berry COVID-19 Anti-Inflammation Trial (ACAI)

University Health Network, Toronto

Status and phase: Unknown; Phase 2

Conditions: COVID

Treatments: Dietary Supplement: Açaí palm berry extract - natural product; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04404218

CTO3176

Details and patient eligibility

About

The Açaí trial will be testing if the açaí berry extract, a safe natural product with anti-inflammatory properties, can be used as a treatment option in adult patients with COVID-19 in the community.

Full description

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 40 years of age; and
• Mild to moderate symptoms including fever, dry cough, and tiredness; and
• Tested positive for SARS-Cov-2, via virological diagnosis (PCR), in the last 7 days; and
• Not hospitalized at the time of randomization, with no limitations on activities; and
• Willingness to complete questionnaires and records associated with the study.

Exclusion criteria

• Hospitalized patients at the time of enrollment; or
• Known allergy to study medication or its non-medicinal ingredients; or
• Currently taking açai extract or juice; or
• Chronic severe renal impairment (creatinine clearance <30 mL/min or on renal replacement therapy); or
• Pregnant or breastfeeding patients; or
• Women who are planning to become pregnant during the study; or
• End-stage cancer or patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention; or
• Unable to provide informed consent; or
• Patients taking antiplatelet/blood-thinning medication; or
• Patients with unstable metabolic disease/chronic diseases/ diseases with any comorbidities and/or any serious medical condition or abnormality of clinical laboratory tests that precludes the patient's safe participation in and completion of the study or puts them in a greater risk of developing severe symptoms (e.g. Individuals with an acute infectious disease, immune-compromised, self-reported confirmation of HIV, other lung diseases such as asthma, emphysema, neurological conditions); or
• Patients who participated in other clinical research studies 30 days prior to screening; or
• Patients who are participating in another clinical trial at the same time.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

Açaí palm berry extract

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Açaí palm berry extract - natural product

Placebo arm

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo