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COVID-19TanCOVIDNCT04403646

Tannin Specific Natural Extract for COVID-19 Infection

A study testing ARBOX in people with COVID-19 and SARS-CoV 2, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, SARS-CoV 2, Coronavirus Infection
What is being tested?
ARBOX
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteArgentina
Study dates
12 Jun 2020to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital de Clinicas

    Buenos Aires, C1120AAF

Other trials in Argentina

About this study

Official title: Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial

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.

Read the 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.

Being tested
ARBOX, PLACEBO
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARBOXDietary supplement

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

  • PLACEBOOther

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

Study groups in NCT04403646
Study groupRoleWhat they receive
TREATEDExperimentalParticipants 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.
Receives: Dietary Supplement: ARBOX
CONTROLPlacebo comparatorParticipants 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.
Receives: Other: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to hospital discharge

    defined as the time from first dose of polyphenol extract to hospital discharge

    Measured: Throughout the Study (Day 0 to Day 28)

Secondary outcomes (5)

  1. 28-day all-cause mortality

    proportion

    Measured: Throughout the Study (Day 0 to Day 28)

  2. invasive ventilation on day 28

    proportion

    Measured: Throughout the Study (Day 0 to Day 28)

  3. Difference in Pro and antiinflammatory citoquine levels

    mean difference

    Measured: day 1-14

  4. Difference in fecal intestinal microbiota composition

    Measured: day 1-14

  5. Negativization of COVID-PCR at day 14

    proportion

    Measured: day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start12 Jun 2020
  3. Primary completion20 Oct 2020
  4. Study completion1 Nov 2020

Why it stopped: low rate of covid patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403646
Sponsor's protocol ID
HCJSM-20-005
Acronym
TanCOVID
Status last verified
Dec 2020
First submitted
22 May 2020
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24498245

  • 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.

    PubMed 23372851

  • 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.

    PubMed 21102377

  • 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.

    PubMed 33910614

Questions about this trial

What is this clinical trial studying?

A study testing ARBOX in people with COVID-19 and SARS-CoV 2, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: low rate of covid patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to hospital discharge (time frame: Throughout the Study (Day 0 to Day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04403646, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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