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

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 		Xylitol + GSE
  • Other: GSE and Xylitol
    Participants are given the experimental treatment to be used for 7 days.
Placebo Comparator
Control placebo 		Saline
  • Drug: Control Placebo
    Saline

Recruiting Locations

More Details

NCT ID
NCT04854486
Status
Withdrawn
Sponsor
Larkin Community Hospital