Status:
UNKNOWN
The Açaí Berry COVID-19 Anti-Inflammation Trial
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
University of Toronto
Conditions:
COVID
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 medi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04404218
Start Date
August 4 2020
End Date
December 1 2022
Last Update
May 31 2022
Active Locations (3)
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1
Instituto de Pesquisas em Saude (IPS)/ Universidade de Caxias do Sul (UCS)
Caxias do Sul, Rio Grande do Sul, Brazil
2
Instituto Prevent Senior (IPS) - Hospital Sancta Maggiore
São Paulo, São Paulo, Brazil
3
Heart Health Institute Research Inc
Toronto, Ontario, Canada, M1B 4Z8