There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.
The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan
throughout China and is being exported to a growing number of countries, some of which have
seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was
associated with 2% mortality. There is currently no vaccine and no specific antiviral
treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of
clinical management is largely symptomatic treatment, with organ support in intensive care
for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic
approach to COVID-19.
Tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and
a regulatory effect on the gastrointestinal metabolism.
The investigators will realize a prospective, double-blind, randomized trial to assess the
effect of treatment with a dietary supplement (ARBOX), a molecular complex of quebracho and
chestnut tannins extract and Vit B12, compared with placebo. 140 COVID-19 patients will be
recruited in a single center in Buenos Aires Argentina. 70 patients will receive conventional
treatment plus ARBOX (treated group) and 70 patients will receive conventional treatment plus
placebo (control group). The effects will be evaluated during the 28 days follow up. The
primary end point will be the time of discharge from the hospital. A panel of 27 cytokines
level, intestinal microbiota composition and its metabolites will be assessed at day 1 and
14.
Dietary Supplement: ARBOX
dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg
Other: PLACEBO
Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX
Inclusion Criteria:
- Over 18 years of age hospitalized in the general hospitalization room, who meet the
definition of "Confirmed case COVID-19"
(https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion -of-case)
Exclusion Criteria:
- Pregnancy
- Lactancy
- Hypersensitivity to polyphenols
- Patients unable to receive oral medication (severe cognitive impairment, assisted
ventilation, impaired state of consciousness)
- Lack of consent
- Participation in any other interventional clinical trial
Hospital de Clinicas
Buenos Aires, Argentina
Maria M Piskorz, MD, Principal Investigator
Hospital de Clinicas Universidad de Buenos Aires