Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
NCT ID: NCT04854486
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2021-12-16
2022-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Group
Xylitol + GSE
GSE and Xylitol
Participants are given the experimental treatment to be used for 7 days.
Control placebo
Saline
Control Placebo
Saline
Interventions
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GSE and Xylitol
Participants are given the experimental treatment to be used for 7 days.
Control Placebo
Saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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Larkin Community Hospital
OTHER
Responsible Party
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Locations
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Larkin Community Hospital Palm Springs Campus
Miami, Florida, United States
Larkin Community Hospital
Miami, Florida, United States
Countries
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Other Identifiers
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LCH-2-112020
Identifier Type: -
Identifier Source: org_study_id
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