COVID
Conditions
Keywords
açaí berry, COVID, community care patients
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.
Interventions
DIETARY_SUPPLEMENTAçaí 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.
OTHERPlacebo
Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
Sponsors
University of Toronto
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinding, using placebo pills.
Intervention model description
Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-point ordinal symptom scale | 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
| Measure | Time frame | Description |
|---|---|---|
| The composite of all-cause mortality and need for mechanical ventilation | 30 days | First occurrence of all-cause mortality or need for mechanical ventilation |
| The composite of all-cause mortality and hospitalization | 30 days | First occurrence of all-cause mortality or hospitalization |
| All-cause mortality | 30 days | All-cause mortality |
| Need for mechanical ventilation | 30 days | Need for mechanical ventilation |
| Need for hospitalization | 30 days | Need for hospitalization |
Countries
Brazil, Canada
Outcome results
None listed