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

Sponsor
Larkin Community Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04610801
Collaborator
Ferrer Medical Innovations (Other), Xlear (Other)
200
Enrollment
2
Locations
3
Arms
8
Anticipated Duration (Months)
100
Patients Per Site
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Nasal Spray
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Care Provider)
Masking Description:
Masking to care providers
Primary Purpose:
Treatment
Official Title:
A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection
Anticipated Study Start Date :
Dec 8, 2021
Anticipated Primary Completion Date :
Jun 8, 2022
Anticipated Study Completion Date :
Aug 8, 2022

Arms and Interventions

ArmIntervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days [Baseline and 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,

    Secondary Outcome Measures

    1. Change of time to clinical recovery from baseline within 7 days [Baseline and 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Larkin Community Hospital Palm Springs CampusMiamiFloridaUnited States33012
    2Larkin Community HospitalMiamiFloridaUnited States33143

    Sponsors and Collaborators

    • Larkin Community Hospital
    • Ferrer Medical Innovations
    • Xlear

    Investigators

    • Principal Investigator: Gustavo Ferrer, MD, Larkin Community Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gustavo Ferrer, M.D., Associate Professor, Larkin Community Hospital
    ClinicalTrials.gov Identifier:
    NCT04610801
    Other Study ID Numbers:
    • LCH-3-082020
    First Posted:
    Nov 2, 2020
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gustavo Ferrer, M.D., Associate Professor, Larkin Community Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021