Evaluation of the Efficacy of Xylitol Nasal Spray Against SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray as an adjunct treatment of COVID-19.

Detailed Description
-----------------
After being informed about the study and potential risk, all patients giving written informed consent will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, patients who meet the eligibility requirements will be randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nosetrils, every 3-4 hours a day) or placebo. Patient will be followed for 1 week. Inflammatory markers will be obtained on Day 4 and repeat COVID-19 RT PCR on Day 7. Follow up will be done on Day 14 for all patients.

Official Title
-----------------
A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Nasal Spray


Participation Criteria
=================
Eligibility 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: 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
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No treatment<br>No treatment given | |
| Experimental: Treatment<br>Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours | Drug: Nasal Spray<br>* Randomized to placebo and Xlear<br>* Other names: Xlear;|
| Placebo Comparator: Placebo<br>Saline nasal spray, 2 puffs per nosetrils, every 6 hours | Drug: Nasal Spray<br>* Randomized to placebo and Xlear<br>* Other names: Xlear;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days | The COVID 19 RT PCR is the gold standard in detecting presence of COVID-19 in patients. The average time from reactivity to non-reactivity is 14 days, | Baseline and 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of time to clinical recovery from baseline within 7 days | Change in clinical symptoms including but not limited to agnosmia, ageusia, fever, congestion and other clinical symptoms associated with mild COVID-19 infection. | Baseline and 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid 19, Intranasal Spray, Therapeutics