Tannin Specific Natural Extract for COVID-19 Infection (TaCOVID)
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|ClinicalTrials.gov Identifier: NCT04403646|
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV 2 Coronavirus Infection||Dietary Supplement: ARBOX Other: PLACEBO||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 31, 2020|
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
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.
Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX
- Time to hospital discharge [ Time Frame: Throughout the Study (Day 0 to Day 28) ]defined as the time from first dose of polyphenol extract to hospital discharge
- 28-day all-cause mortality [ Time Frame: Throughout the Study (Day 0 to Day 28) ]proportion
- invasive ventilation on day 28 [ Time Frame: Throughout the Study (Day 0 to Day 28) ]proportion
- Difference in Pro and antiinflammatory citoquine levels [ Time Frame: day 1-14 ]mean difference
- Difference in fecal intestinal microbiota composition [ Time Frame: day 1-14 ]
- Negativization of COVID-PCR at day 14 [ Time Frame: day 14 ]proportion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403646
|Contact: Maria M Piskorz, MDemail@example.com|