Covid19
Conditions
Keywords
Covid 19, Intranasal Spray, Therapeutics
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.
Detailed description
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.
Interventions
DRUGNasal Spray
Randomized to placebo and Xlear
Sponsors
Ferrer Medical Innovations
Xlear, Inc
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days | Baseline and 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of time to clinical recovery from baseline within 7 days | Baseline and 7 days | Change in clinical symptoms including but not limited to agnosmia, ageusia, fever, congestion and other clinical symptoms associated with mild COVID-19 infection. |
Countries
United States
Outcome results
None listed