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

Larkin Community Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Covid19

Treatments: Drug: Control Placebo; Other: GSE and Xylitol

Study type: Interventional

Funder types: Other

Identifiers

NCT04854486

LCH-2-112020

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Xylitol + GSE

Treatment:

Other: GSE and Xylitol

Control placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Control Placebo