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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Other: GSE and Xylitol
* Drug: Control Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Xylitol + GSE | Other: GSE and Xylitol<br>* Participants are given the experimental treatment to be used for 7 days.<br>|
| Placebo Comparator: Control placebo<br>Saline | Drug: Control Placebo<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal spray, Covid19