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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04610801

Run by

Larkin Community Hospital

People needed

0

Starts

2021-12-08

Expected to finish

2022-08-08

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Larkin Community Hospital Palm Springs Campus — Miami, Florida, United States
• Larkin Community Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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