Status:
WITHDRAWN
Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
Lead Sponsor:
Larkin Community Hospital
Conditions:
Covid19
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04854486
Start Date
December 16 2021
End Date
November 16 2022
Last Update
October 16 2023
Active Locations (2)
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1
Larkin Community Hospital Palm Springs Campus
Miami, Florida, United States, 33012
2
Larkin Community Hospital
Miami, Florida, United States, 33143