Covid19 Clinical Trial
Official title:
Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
Verified date | October 2023 |
Source | Larkin Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 16, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Larkin Community Hospital | Miami | Florida |
United States | Larkin Community Hospital Palm Springs Campus | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Larkin Community Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of time to negativisation via PCR | There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result. | Baseline and 7 days |
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