Tannin Specific Natural Extract for COVID-19 Infection

Not Applicable

Terminated

• Conditions: COVID-19; Coronavirus Infection; SARS-CoV 2

• Registration Number: NCT04403646
• Lead Sponsor: Hospital de Clinicas José de San Martín

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-06-12
• Primary Completion: 2020-10-20
• Study Completion: 2020-11-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to hospital discharge	Throughout the Study (Day 0 to Day 28)	defined as the time from first dose of polyphenol extract to hospital discharge

Secondary Outcome Measures

Name	Time	Method
28-day all-cause mortality	Throughout the Study (Day 0 to Day 28)	proportion
Difference in Pro and antiinflammatory citoquine levels	day 1-14	mean difference
Negativization of COVID-PCR at day 14	day 14	proportion
invasive ventilation on day 28	Throughout the Study (Day 0 to Day 28)	proportion
Difference in fecal intestinal microbiota composition	day 1-14

Trial Locations

Locations (1)

Hospital de Clinicas; 🇦🇷 Buenos Aires, Argentina