A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection

Purpose

This study aims to find out the efficacy of Xlear nasal spray as an adjunct medication against COVID-19. This encompasses reduction in the number of days to negativization via nasal swab PCR from the average 14 days and early improvement of symptoms.

Condition

  • Covid19

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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. Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test 5. 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 2 liters 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 grapefruit seed extract (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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Care Provider)
Masking Description
Masking to care providers

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
No treatment
Experimental
Treatment
  • Drug: Xlear Nasal Spray
    Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
Placebo Comparator
Placebo 		Saline nasal spray, 2 puffs per nostrils, every 6 hours
  • Drug: Placebo
    Saline nasal spray, 2 puffs per nostrils, every 6 hours

Recruiting Locations

More Details

NCT ID
NCT04858620
Status
Withdrawn
Sponsor
Larkin Community Hospital

Detailed Description

Patients will be informed about the study including potential risk and benefits. Once written informed consent are obtained, patients will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, eligible patients will be placed in a randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nostrils, 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 Reverse Transcriptase PCR (RT PCR) on Day 7. Follow up will be done on Day 14 for all patients.