NCT04854486

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

April 17, 2021

Last Update Submit

October 12, 2023

Conditions

Covid19

Keywords

intranasal sprayCovid19

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 7 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

Xylitol + GSE

Other: GSE and Xylitol

Control placebo

PLACEBO COMPARATOR

Saline

Drug: Control Placebo

Interventions

GSE and XylitolOTHER

Participants are given the experimental treatment to be used for 7 days.

Treatment Group
Control PlaceboDRUG

Saline

Control placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of ages 18 to 90 years of both sexes
  • With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
  • Signed informed consent
  • Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Larkin Community Hospital Palm Springs Campus

Miami, Florida, 33012, United States

Location

Larkin Community Hospital

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placebo controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2021

First Posted

April 22, 2021

Study Start

December 16, 2021

Primary Completion

March 30, 2022

Study Completion

November 16, 2022

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)