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

Last updated: October 12, 2023
Sponsor: Larkin Community Hospital
Overall Status: Trial Not Available

Phase

3

Condition

Covid-19

Treatment

Nasal Spray

Clinical Study ID

NCT04610801
LCH-3-082020
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 breathwith mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92%with 2lt of oxygen)

Exclusion

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 tobecome 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 tothe Standard of Care protocol.
  6. Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liternon-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 ChronicObstructive 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

Treatment Group(s): 1
Primary Treatment: Nasal Spray
Phase: 3
Study Start date:
December 08, 2021
Estimated Completion Date:
August 08, 2022

Study 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.

Connect with a study center

  • Larkin Community Hospital

    Miami, Florida 33143
    United States

    Site Not Available

  • Larkin Community Hospital Palm Springs Campus

    Miami, Florida 33012
    United States

    Site Not Available

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