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

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ClinicalTrials.gov Identifier: NCT04404218
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Michael Farkouh, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
COVID Dietary Supplement: Açaí palm berry extract - natural product Other: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinding, using placebo pills.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
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 - natural product
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
Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.




Primary Outcome Measures :
  1. 7-point ordinal symptom scale [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. The composite of all-cause mortality and need for mechanical ventilation [ Time Frame: 30 days ]
    First occurrence of all-cause mortality or need for mechanical ventilation

  2. The composite of all-cause mortality and hospitalization [ Time Frame: 30 days ]
    First occurrence of all-cause mortality or hospitalization

  3. All-cause mortality [ Time Frame: 30 days ]
    All-cause mortality

  4. Need for mechanical ventilation [ Time Frame: 30 days ]
    Need for mechanical ventilation

  5. Need for hospitalization [ Time Frame: 30 days ]
    Need for hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404218


Contacts
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Contact: Hassan Ellaban 416-340-4800 ext 8440 Hassan.Ellaban@uhn.ca

Locations
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Canada, Ontario
Heart Health Institute Research Inc Recruiting
Toronto, Ontario, Canada, M1B 4Z8
Contact: Ravendra Sarwan    647-344-4476    hhiresearch@hearthealthinstitute.net   
Principal Investigator: Vineeta Ahooja, MD         
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Investigators
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Principal Investigator: 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
Publications:
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.

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Responsible Party: Michael Farkouh, Chair & Director, Peter Munk Centre of Excellence in Multinational Clinical Trials, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04404218    
Other Study ID Numbers: CTO3176
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Farkouh, University Health Network, Toronto:
açaí berry
COVID
community care patients