Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2022-11-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Larkin Community Hospital

Criteria

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.