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

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nasal Spray
Sponsored by
Larkin Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid 19, Intranasal Spray, Therapeutics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Larkin Community Hospital Palm Springs Campus
  • Larkin Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Placebo Comparator

Arm Label

No treatment

Treatment

Placebo

Arm Description

No treatment given

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

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

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

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.

Full Information

First Posted
October 26, 2020
Last Updated
October 12, 2023
Sponsor
Larkin Community Hospital
Collaborators
Ferrer Medical Innovations, Xlear, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04610801
Brief Title
Evaluation of the Efficacy of Xylitol Nasal Spray Against SARS-CoV-2
Official Title
A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study Period Ended/ Not Completed
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Larkin Community Hospital
Collaborators
Ferrer Medical Innovations, Xlear, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid 19, Intranasal Spray, Therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Masking Description
Masking to care providers
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment given
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline nasal spray, 2 puffs per nosetrils, every 6 hours
Intervention Type
Drug
Intervention Name(s)
Nasal Spray
Other Intervention Name(s)
Xlear
Intervention Description
Randomized to placebo and Xlear
Primary Outcome Measure Information:
Title
Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days
Description
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,
Time Frame
Baseline and 7 days
Secondary Outcome Measure Information:
Title
Change of time to clinical recovery from baseline within 7 days
Description
Change in clinical symptoms including but not limited to agnosmia, ageusia, fever, congestion and other clinical symptoms associated with mild COVID-19 infection.
Time Frame
Baseline and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Ferrer, MD
Organizational Affiliation
Larkin Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larkin Community Hospital Palm Springs Campus
City
Miami
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Larkin Community Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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