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.
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.
Drug: Nasal Spray
Randomized to placebo and Xlear
Other Name: Xlear
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.
Larkin Community Hospital Palm Springs Campus
Miami, Florida, United States
Larkin Community Hospital
Miami, Florida, United States
Roboam R Aguirre, MD, DBA
305-284-7608
raguirre@larkinhospital.com
Marcos Sanchez-Gonzalez, Md, PhD
masanchez@larkinhospital.com
Gustavo Ferrer, MD, Principal Investigator
Larkin Community Hospital