An interventional study of ARBOX and PLACEBO in COVID-19, SARS-CoV 2 and Coronavirus Infection, sponsored by Hospital de Clinicas José de San Martín. Terminated at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Hospital de Clinicas José de San Martín · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 124 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hospital de Clinicas José de San Martín is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Participants will receive a supply of 28 -- 390 mg ARBOX capsules for 14 days. Patients will be supplemented with 2 capsules of ARBOX per day and standard therapy. Standard treatment includes: Antipyretics or Lopinavir / Ritonavir, Azithromycin and Hydroxychloroquine, as appropriate (treatment currently recommended by the department of Infectious Diseases of the Hospital de Clínicas that could undergo to modifications). In addition, if necessary: supplemental O2, non-invasive ventilation, antibiotic therapy.
Dietary Supplement: ARBOX
Participants will receive placebo supply for 14 days. The placebo will be administrated with the identical dose as described for the test product. Beside patients will receive the standard theraphy, which includes Antipyretics or Lopinavir / Ritonavir, Azithromycin and Hydroxychloroquine, as appropriate (treatment currently recommended by the department of Infectious Diseases of the Hospital de Clínicas that could undergo to modifications). In addition, if necessary: supplemental O2, non-invasive ventilation, antibiotic therapy.
Other: PLACEBO
dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg
Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX
Time to hospital discharge
defined as the time from first dose of polyphenol extract to hospital discharge
Time frame: Throughout the Study (Day 0 to Day 28)
28-day all-cause mortality
proportion
Time frame: Throughout the Study (Day 0 to Day 28)
invasive ventilation on day 28
proportion
Time frame: Throughout the Study (Day 0 to Day 28)
Difference in Pro and antiinflammatory citoquine levels
mean difference
Time frame: day 1-14
Difference in fecal intestinal microbiota composition
Time frame: day 1-14
Negativization of COVID-PCR at day 14
proportion
Time frame: day 14
Plan to share: Undecided
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas José de San Martín