The Açaí Berry COVID-19 Anti-Inflammation Trial

NCT04404218 | Unknown Phase 2

• 1 other identifier: CTO3176
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

COVID

Keywords

açaí berry; COVID; community care patients

Outcome Measures

Primary Outcomes (1)

• 7-point ordinal symptom scale

  Symptom comparison between patients from the treatment vs control group, using an ordinal symptom scale based on the WHO scale. Patients who were hospitalized will be classified according to their worst score over 30 days and non-hospitalized patients according to their score at 30 days.

  30 days

Secondary Outcomes (5)

• The composite of all-cause mortality and need for mechanical ventilation

  30 days

• The composite of all-cause mortality and hospitalization

  30 days

• All-cause mortality

  30 days

• Need for mechanical ventilation

  30 days

• Need for hospitalization

  30 days

Study Arms (2)

Açaí palm berry extract

EXPERIMENTAL

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 - natural product

Placebo arm

PLACEBO COMPARATOR

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

Interventions

Açaí palm berry extract - natural product DIETARY_SUPPLEMENT

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.

Açaí palm berry extract

Placebo OTHER

Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.

Placebo arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Study Sites (3)

Instituto de Pesquisas em Saude (IPS)/ Universidade de Caxias do Sul (UCS)

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Instituto Prevent Senior (IPS) - Hospital Sancta Maggiore

São Paulo, São Paulo, Brazil

Location

Heart Health Institute Research Inc

Toronto, Ontario, M1B 4Z8, Canada

Location

Related Publications (6)

• Machado AK, Andreazza AC, da Silva TM, Boligon AA, do Nascimento V, Scola G, Duong A, Cadona FC, Ribeiro EE, da Cruz IB. Neuroprotective Effects of Acai (Euterpe oleracea Mart.) against Rotenone In Vitro Exposure. Oxid Med Cell Longev. 2016;2016:8940850. doi: 10.1155/2016/8940850. Epub 2016 Oct 3.

  PMID: 27781077 BACKGROUND

• Machado AK, Cadoná FC, Assmann CE, Andreazza AC, Duarte MMMF, Branco CS, Zhou X, Souza DV, Ribeiro EE, Cruz IBM. Açaí (Euterpe oleracea Mart.) has anti-inflammatory potential through NLRP3-inflammasome modulation. Journal of Functional Foods. Volume 56, 2019, Pages 364-371, https://doi.org/10.1016/j.jff.2019.03.034.

  BACKGROUND

• Kim HK, Chen W, Andreazza AC. The Potential Role of the NLRP3 Inflammasome as a Link between Mitochondrial Complex I Dysfunction and Inflammation in Bipolar Disorder. Neural Plast. 2015;2015:408136. doi: 10.1155/2015/408136. Epub 2015 May 13.

  PMID: 26075098 BACKGROUND

• Kim HK, Andreazza AC, Elmi N, Chen W, Young LT. Nod-like receptor pyrin containing 3 (NLRP3) in the post-mortem frontal cortex from patients with bipolar disorder: A potential mediator between mitochondria and immune-activation. J Psychiatr Res. 2016 Jan;72:43-50. doi: 10.1016/j.jpsychires.2015.10.015. Epub 2015 Oct 26.

  PMID: 26540403 BACKGROUND

• Ulbricht C, Brigham A, Burke D, Costa D, Giese N, Iovin R, Grimes Serrano JM, Tanguay-Colucci S, Weissner W, Windsor R. An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration. J Diet Suppl. 2012 Jun;9(2):128-47. doi: 10.3109/19390211.2012.686347.

  PMID: 22607647 BACKGROUND

• Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.

  PMID: 32187464 BACKGROUND

Study Officials

• Michael Farkouh, MD, MSc

  Peter Munk Cardiac Centre; University Health Network; University of Toronto

  PRINCIPAL INVESTIGATOR

• Ana Andreazza, PhD

  Department of Pharmacology & Toxicology; University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding, using placebo pills.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair & Director, Peter Munk Centre of Excellence in Multinational Clinical Trials

Model Details: Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 27, 2020
• Study Start: August 4, 2020
• Primary Completion: June 15, 2022
• Study Completion: December 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2); CA (1)