Tannin Specific Natural Extract for COVID-19 Infection

NCT04403646 | Terminated

• 1 other identifier: HCJSM-20-005
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV 2; Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• Time to hospital discharge

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

  Throughout the Study (Day 0 to Day 28)

Secondary Outcomes (5)

• 28-day all-cause mortality

  Throughout the Study (Day 0 to Day 28)

• invasive ventilation on day 28

  Throughout the Study (Day 0 to Day 28)

• Difference in Pro and antiinflammatory citoquine levels

  day 1-14

• Difference in fecal intestinal microbiota composition

  day 1-14

• Negativization of COVID-PCR at day 14

  day 14

Study Arms (2)

TREATED

EXPERIMENTAL

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

CONTROL

PLACEBO COMPARATOR

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

Interventions

ARBOX DIETARY_SUPPLEMENT

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

TREATED

PLACEBO OTHER

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

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead
• SILVATEAM: collaborator

Study Sites (1)

Hospital de Clinicas

Buenos Aires, C1120AAF, Argentina

Location

Related Publications (4)

• 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.

  PMID: 24498245 BACKGROUND

• 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.

  PMID: 23372851 BACKGROUND

• 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.

  PMID: 21102377 BACKGROUND

• 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.

  PMID: 33910614 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maria M Piskorz, MD

  Hospital de Clinicas Universidad de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurogastroenterologist at Hospital de Clinicas, Principal Investigator

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: June 12, 2020
• Primary Completion: October 20, 2020
• Study Completion: November 1, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

AR (1)