Clinical trial NCT04610801: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid19
Keywords: Covid 19
Intranasal Spray
Therapeutics
Lead sponsor: Larkin Community Hospital
Sponsor class: OTHER
Collaborators: name: Ferrer Medical Innovations
name: Xlear, Inc
First posted: 2020-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Change of time to clinical recovery from baseline within 7 days
timeFrame: Baseline and 7 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Larkin Community Hospital Palm Springs Campus
state: Florida
city: Miami
country: United States
facility: Larkin Community Hospital
state: Florida
Study officials:
affiliation: Larkin Community Hospital
name: Gustavo Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
References: