Tannin Specific Natural Extract for COVID-19 Infection
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 05/21/2020 |
| Estimated Enrollment Submitted: | 05/25/2020 |
| First Posted: | 05/26/2020 |
| Last Update Submitted: | 05/25/2020 |
| Last Update Posted: | 05/26/2020 |
| Actual Study Start Date: | 05/31/2020 |
| Estimated Primary Completion Date: | 09/29/2020 |
| Estimated Study Completion Date: | 10/30/2020 |
Condition or disease
Intervention/treatment
Dietary Supplement: TREATED
Other: CONTROL
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | Dietary Supplement: TREATED dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg |
| Placebo Comparator: 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. | Other: CONTROL Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Time to hospital discharge [Throughout the Study (Day 0 to Day 28)]
Secondary Outcome Measures
1. 28-day all-cause mortality [Throughout the Study (Day 0 to Day 28)]
2. invasive ventilation on day 28 [Throughout the Study (Day 0 to Day 28)]
3. Difference in Pro and antiinflammatory citoquine levels [day 1-14]
4. Difference in fecal intestinal microbiota composition [day 1-14]
5. Negativization of COVID-PCR at day 14 [day 14]
