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Tannin Specific Natural Extract for COVID-19 Infection

NCT ID: NCT04403646

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2020-11-01

Brief Summary

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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

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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.

Conditions

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COVID-19 SARS-CoV 2 Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TREATED

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.

Group Type EXPERIMENTAL

ARBOX

Intervention Type DIETARY_SUPPLEMENT

dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg

CONTROL

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.

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX

Interventions

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ARBOX

dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SILVATEAM

UNKNOWN

Sponsor Role collaborator

Hospital de Clinicas José de San Martín

OTHER

Sponsor Role lead

Responsible Party

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Maria Marta Piskorz

Neurogastroenterologist at Hospital de Clinicas, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria M Piskorz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas Universidad de Buenos Aires

Locations

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Hospital de Clinicas

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

References

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Theisen LL, Erdelmeier CA, Spoden GA, Boukhallouk F, Sausy A, Florin L, Muller CP. Tannins from Hamamelis virginiana bark extract: characterization and improvement of the antiviral efficacy against influenza A virus and human papillomavirus. PLoS One. 2014 Jan 31;9(1):e88062. doi: 10.1371/journal.pone.0088062. eCollection 2014.

Reference Type BACKGROUND
PMID: 24498245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23372851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21102377 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33910614 (View on PubMed)

Other Identifiers

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HCJSM-20-005

Identifier Type: -

Identifier Source: org_study_id