Clinical trial NCT04403646: Tannin Specific Natural Extract for COVID-19 Infection
Official title: Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
SARS-CoV 2
Coronavirus Infection
Lead sponsor: Hospital de Clinicas José de San Martín
Sponsor class: OTHER
Collaborators: name: SILVATEAM
First posted: 2020-05-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to hospital discharge
timeFrame: Throughout the Study (Day 0 to Day 28)
Secondary outcomes:
measure: 28-day all-cause mortality
timeFrame: Throughout the Study (Day 0 to Day 28)
measure: invasive ventilation on day 28
timeFrame: Throughout the Study (Day 0 to Day 28)
measure: Difference in Pro and antiinflammatory citoquine levels
timeFrame: day 1-14
measure: Difference in fecal intestinal microbiota composition
timeFrame: day 1-14
measure: Negativization of COVID-PCR at day 14
timeFrame: day 14
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas
Study officials:
affiliation: Hospital de Clinicas Universidad de Buenos Aires
name: Maria M Piskorz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ueda K, Kawabata R, Irie T, Nakai Y, Tohya Y, Sakaguchi T. Inactivation of pathogenic viruses by plant-derived tannins: strong effects of extracts from persimmon (Diospyros kaki) on a broad range of viruses. PLoS One. 2013;8(1):e55343. doi: 10.1371/journal.pone.0055343. Epub 2013 Jan 25.
citation: Zhang L, Cheng YX, Liu AL, Wang HD, Wang YL, Du GH. Antioxidant, anti-inflammatory and anti-influenza properties of components from Chaenomeles speciosa. Molecules. 2010 Nov 22;15(11):8507-17. doi: 10.3390/molecules15118507.
citation: Molino S, Pisarevsky A, Mingorance FL, Vega P, Stefanolo JP, Repetti J, Luduena G, Pepa P, Olmos JI, Fermepin MR, Uehara T, Villapol S, Savidge T, Treangen T, Viciani E, Castagnetti A, Piskorz MM. Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 Apr 28;22(1):310. doi: 10.1186/s13063-021-05281-x.