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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Care Provider)
Masking Description
Masking to care providers

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
No treatment 		No treatment given
Experimental
Treatment 		Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours
  • Drug: Nasal Spray
    Randomized to placebo and Xlear
    Other names:
    • Xlear
Placebo Comparator
Placebo 		Saline nasal spray, 2 puffs per nosetrils, every 6 hours
  • Drug: Nasal Spray
    Randomized to placebo and Xlear
    Other names:
    • Xlear

Recruiting Locations

More Details

NCT ID
NCT04610801
Status
Withdrawn
Sponsor
Larkin Community Hospital

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.