the açaí berry covid-19 anti-inflammation trial

Conditions: COVID

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.

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.

Eligibility 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.

Keywords: açaí berry covid community care patients