COVID Clinical Trial
— ACAIOfficial title:
Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19
Verified date | May 2022 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 480 |
Est. completion date | December 2022 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Pesquisas em Saude (IPS)/ Universidade de Caxias do Sul (UCS) | Caxias Do Sul | RS |
Brazil | Instituto Prevent Senior (IPS) - Hospital Sancta Maggiore | Sao Paulo | SP |
Canada | Heart Health Institute Research Inc | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | University of Toronto |
Brazil, Canada,
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18. — View Citation
Kim HK, Andreazza AC, Elmi N, Chen W, Young LT. Nod-like receptor pyrin containing 3 (NLRP3) in the post-mortem frontal cortex from patients with bipolar disorder: A potential mediator between mitochondria and immune-activation. J Psychiatr Res. 2016 Jan;72:43-50. doi: 10.1016/j.jpsychires.2015.10.015. Epub 2015 Oct 26. — View Citation
Kim HK, Chen W, Andreazza AC. The Potential Role of the NLRP3 Inflammasome as a Link between Mitochondrial Complex I Dysfunction and Inflammation in Bipolar Disorder. Neural Plast. 2015;2015:408136. doi: 10.1155/2015/408136. Epub 2015 May 13. Review. — View Citation
Machado AK, Andreazza AC, da Silva TM, Boligon AA, do Nascimento V, Scola G, Duong A, Cadoná FC, Ribeiro EE, da Cruz IB. Neuroprotective Effects of Açaí (Euterpe oleracea Mart.) against Rotenone In Vitro Exposure. Oxid Med Cell Longev. 2016;2016:8940850. Epub 2016 Oct 3. — View Citation
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.
Ulbricht C, Brigham A, Burke D, Costa D, Giese N, Iovin R, Grimes Serrano JM, Tanguay-Colucci S, Weissner W, Windsor R. An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration. J Diet Suppl. 2012 Jun;9(2):128-47. doi: 10.3109/19390211.2012.686347. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-point ordinal symptom scale | 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. | 30 days | |
Secondary | The composite of all-cause mortality and need for mechanical ventilation | First occurrence of all-cause mortality or need for mechanical ventilation | 30 days | |
Secondary | The composite of all-cause mortality and hospitalization | First occurrence of all-cause mortality or hospitalization | 30 days | |
Secondary | All-cause mortality | All-cause mortality | 30 days | |
Secondary | Need for mechanical ventilation | Need for mechanical ventilation | 30 days | |
Secondary | Need for hospitalization | Need for hospitalization | 30 days |
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