Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
Purpose
This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.
Condition
- Covid19
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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)
Exclusion Criteria
- Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded) - 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Placebo controlled
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
Xylitol + GSE |
|
|
Placebo Comparator Control placebo |
Saline |
|
Recruiting Locations
More Details
- NCT ID
- NCT04854486
- Status
- Withdrawn
- Sponsor
- Larkin Community Hospital