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

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GSE and Xylitol
Control Placebo
Sponsored by
Larkin Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring intranasal spray, Covid19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Larkin Community Hospital Palm Springs Campus
  • Larkin Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control placebo

Arm Description

Xylitol + GSE

Saline

Outcomes

Primary Outcome Measures

Change of time to negativisation via PCR
There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2021
Last Updated
October 12, 2023
Sponsor
Larkin Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04854486
Brief Title
Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
Official Title
Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study Period Ended / Not Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Larkin Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
intranasal spray, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Xylitol + GSE
Arm Title
Control placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Other
Intervention Name(s)
GSE and Xylitol
Intervention Description
Participants are given the experimental treatment to be used for 7 days.
Intervention Type
Drug
Intervention Name(s)
Control Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Change of time to negativisation via PCR
Description
There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.
Time Frame
Baseline and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Larkin Community Hospital Palm Springs Campus
City
Miami
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Larkin Community Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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