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)
• Enrollment: 200
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 8
• Patients Per Site: 100
• Patients Per Site Per Month: 12.5

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 Disease	Intervention/Treatment	Phase
Covid19	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Larkin Community Hospital Palm Springs Campus	Miami	Florida	United States	33012
2	Larkin Community Hospital	Miami	Florida	United States	33143

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: Covid 19; Intranasal Spray; Therapeutics
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 7, 2021