标题：Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial
摘要：Objectives
This research aims to study the efficacy of tannins co-supplementation on disease duration, severity and clinical symptoms, microbiota composition and inflammatory mediators in SARS-CoV2 patients.
Trial design
This is a prospective, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy of the administration of the dietary supplement ARBOX, a molecular blend of quebracho and chestnut tannins extract and Vit B12, in patients affected by COVID-19.
Participants
18 years of age or older, admitted to Hospital de Clinicas Jose de San Martin, Buenos Aires University (Argentina), meeting the definition of "COVID-19 confirmed case" (
https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion-de-caso).
Inclusion Criteria
Participants are eligible to be included in the study if the following criteria apply:
Any gender
≥18 years old
Informed consent for participation in the study
Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Pregnant and lactating patients
Patients who cannot take oral therapy (with severe cognitive decline, assisted ventilation, or impaired consciousness)
Hypersensitivity to polyphenols
Patients already in ICU or requiring mechanical ventilation
Patients already enrolled in other clinical trials
Decline of consent
Intervention and comparator
Experimental:
TREATED ARM
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.
Placebo Comparator:
CONTROL ARM
Participants will receive placebo supply for 14 days. The placebo will be administered with the identical dose as described for the test product.
All trial participants will receive standard therapy, 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.
Main outcomes
Primary Outcome Measures:
Time to hospital discharge, defined as the time from first dose of ARBOX to hospital discharge [ Time Frame: Throughout the Study (Day 0 to Day 28)
