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

Sponsor

Larkin Community Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04854486

Collaborator

(none)

250

Enrollment

Locations

Arms

Anticipated Duration (Months)

125

Patients Per Site

11.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: GSE and Xylitol Drug: Control Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo controlledPlacebo controlled

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 16, 2021

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Nov 16, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of time to negativisation via PCR [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Larkin Community Hospital Palm Springs Campus	Miami	Florida	United States	33012
2	Larkin Community Hospital	Miami	Florida	United States	33143

Sponsors and Collaborators

Larkin Community Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustavo Ferrer, M.D., Principal Investigator, Larkin Community Hospital

ClinicalTrials.gov Identifier:

NCT04854486

Other Study ID Numbers:

LCH-2-112020

First Posted:

Apr 22, 2021

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gustavo Ferrer, M.D., Principal Investigator, Larkin Community Hospital

intranasal spray

Covid19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 14, 2021