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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04854486
• Other study ID #: LCH-2-112020
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 16, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: October 2023
• Source: Larkin Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 16, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• GSE and Xylitol
Participants are given the experimental treatment to be used for 7 days.

Drug:
• Control Placebo
Saline

Locations

Country	Name	City	State
United States	Larkin Community Hospital	Miami	Florida
United States	Larkin Community Hospital Palm Springs Campus	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Larkin Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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