Covid19
Conditions
Brief summary
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.
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.
Interventions
DRUGXlear Nasal Spray
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
DRUGPlacebo
Saline nasal spray, 2 puffs per nostrils, every 6 hours
Sponsors
Larkin Community Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Masking to care providers
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hasten baseline reactive to non-reactive on COVID 19 RT PCR | Baseline and 7 days | The COVID 19 RT PCR is the gold standard in the detection of COVID 19 in patients. With the average time to negativization being 14 days. This study aims to reduce the reactivity to 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of symptoms | Baseline and 7 days | Monitor changes in daily symptoms for COVID 19 positive patients using Symptom Assessment Scale (SAS). Symptoms are classified as Mild, Moderate, Severe. |
Countries
United States
Outcome results
None listed