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

Covid19 Clinical Trial

Official title:

A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04610801
• Other study ID #: LCH-3-082020
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 8, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: October 2023
• Source: Larkin Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Nasal Spray
Randomized to placebo and Xlear

Locations

Country	Name	City	State
United States	Larkin Community Hospital	Miami	Florida
United States	Larkin Community Hospital Palm Springs Campus	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Larkin Community Hospital	Ferrer Medical Innovations, Xlear, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	Baseline and 7 days
Secondary	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.	Baseline and 7 days