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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

Tracking Information
First Submitted Date  ICMJE May 24, 2020
First Posted Date  ICMJE May 27, 2020
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE August 4, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2020)
  • 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
  • The composite of all-cause mortality and hospitalization [ Time Frame: 30 days ]
    First occurrence of all-cause mortality or hospitalization
  • All-cause mortality [ Time Frame: 30 days ]
    All-cause mortality
  • Need for mechanical ventilation [ Time Frame: 30 days ]
    Need for mechanical ventilation
  • Need for hospitalization [ Time Frame: 30 days ]
    Need for hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Açaí Berry COVID-19 Anti-Inflammation Trial
Official Title  ICMJE Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE COVID
Intervention  ICMJE
  • 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.
  • Other: Placebo
    Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Açaí palm berry extract - natural product
  • 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.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2020)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hassan Ellaban 416-340-4800 ext 8440 Hassan.Ellaban@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04404218
Other Study ID Numbers  ICMJE CTO3176
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Farkouh, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE University of Toronto
Investigators  ICMJE
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
PRS Account University Health Network, Toronto
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP