Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients

October 12, 2023 updated by: Larkin Community Hospital

Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection

This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Larkin Community Hospital
      • Miami, Florida, United States, 33012
        • Larkin Community Hospital Palm Springs Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Adults of ages 18 to 90 years of both sexes
  • With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
  • Signed informed consent
  • 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
  • 2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92% with 2lt of oxygen)

Exclusion Criteria

  • Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
  • Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
  • Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
  • Under 18 years of age
  • Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
  • Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
  • Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non- concentrated oxygen) plus severe shortness of breath
  • History of immunodeficiency or are currently receiving immunosuppressive therapy.
  • Have had a planned surgical procedure within the past 12 weeks.
  • Already part of this trial, recruited at a different hospital.
  • Patient unable to perform oro-nasopharyngeal decolonization
  • Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
  • Patients on Remdesivir and/or other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Xylitol + GSE
Other: GSE and Xylitol
Participants are given the experimental treatment to be used for 7 days.
Placebo Comparator: Control placebo
Saline
Drug: Control Placebo
Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of time to negativisation via PCR
Time Frame: Baseline and 7 days
There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.
Baseline and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larkin Community Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

April 17, 2021

First Submitted That Met QC Criteria

April 17, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCH-2-112020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on GSE and Xylitol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe