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

NCT04610801 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: LCH-3-082020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

Covid 19; Intranasal Spray; Therapeutics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of time to clinical recovery from baseline within 7 days

  Baseline and 7 days

Study Arms (3)

No treatment

NO INTERVENTION

No treatment given

Treatment

EXPERIMENTAL

Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours

Drug: Nasal Spray

Placebo

PLACEBO COMPARATOR

Saline nasal spray, 2 puffs per nosetrils, every 6 hours

Drug: Nasal Spray

Interventions

Nasal Spray DRUG

Randomized to placebo and Xlear

Also known as: Xlear

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
• 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.

Sponsors & Collaborators

• Larkin Community Hospital: lead
• Ferrer Medical Innovations: collaborator
• Xlear, Inc: collaborator

Study Sites (2)

Larkin Community Hospital Palm Springs Campus

Miami, Florida, 33012, United States

Location

Larkin Community Hospital

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nasal Sprays; xylitol and grapefruit seed extract drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gustavo Ferrer, MD

  Larkin Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Masking to care providers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: December 8, 2021
• Primary Completion: June 8, 2022
• Study Completion: August 8, 2022
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)