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

Larkin Community Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Covid19

Treatments: Drug: Nasal Spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04610801

LCH-3-082020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults of ages 18 to 90 years of both sexes
2. With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
3. Signed informed consent
4. 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
5. 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

1. Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
2. Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
3. Under 18 years of age
4. 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.
5. Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
6. Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath
7. History of immunodeficiency or are currently receiving immunosuppressive therapy.
8. Have had a planned surgical procedure within the past 12 weeks.
9. Already part of this trial, recruited at a different hospital.
10. Patient unable to perform oro-nasopharyngeal decolonization
11. 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
12. Patients on Remdesivir and/or other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

No treatment

No Intervention group

Description:

No treatment given

Treatment

Experimental group

Description:

Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours

Treatment:

Drug: Nasal Spray

Placebo

Placebo Comparator group

Description:

Saline nasal spray, 2 puffs per nosetrils, every 6 hours

Treatment:

Drug: Nasal Spray